SIST EN ISO 6877:2025

SLOVENSKI STANDARD
01-november-2025
Nadomešča:
SIST EN ISO 6877:2021
Zobozdravstvo - Endodontski materiali za polnitev koreninskih kanalov
(obturacijo) (ISO 6877:2025)
Dentistry - Endodontic obturating materials (ISO 6877:2025)
Zahnheilkunde - Endodontische Obturationswerkstoffe (ISO 6877:2025)
Médecine bucco-dentaire - Matériaux d’obturation endodontique (ISO 6877:2025)
Ta slovenski standard je istoveten z: EN ISO 6877:2025
ICS:
11.060.10 Zobotehnični materiali Dental materials
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 6877
EUROPEAN STANDARD
NORME EUROPÉENNE
August 2025
EUROPÄISCHE NORM
ICS 11.060.10 Supersedes EN ISO 6877:2021
English Version
Dentistry - Endodontic obturating materials (ISO
6877:2025)
Médecine bucco-dentaire - Matériaux d'obturation Zahnheilkunde - Endodontische Obturationswerkstoffe
endodontique (ISO 6877:2025) (ISO 6877:2025)
This European Standard was approved by CEN on 25 May 2025.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 6877:2025 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 6877:2025) has been prepared by Technical Committee ISO/TC 106 "Dentistry"
in collaboration with Technical Committee CEN/TC 55 “Dentistry” the secretariat of which is held by
DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by February 2026, and conflicting national standards
shall be withdrawn at the latest by February 2026.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 6877:2021.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 6877:2025 has been approved by CEN as EN ISO 6877:2025 without any modification.

International
Standard
ISO 6877
Fourth edition
Dentistry — Endodontic obturating
2025-08
materials
Médecine bucco-dentaire — Matériaux d’obturation
endodontique
Reference number
ISO 6877:2025(en) © ISO 2025
ISO 6877:2025(en)
© ISO 2025
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
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CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 6877:2025(en)
Contents Page
Foreword .iv
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 3
4.1 Appearance .3
4.2 Length .3
4.3 Designation and nominal size .4
4.4 Tolerances .4
4.5 Colour-coding .4
4.6 Taper .4
4.7 Carrier-based obturating device .7
4.8 Physical integrity .8
4.9 Radiopacity .8
5 Procurement of samples . 8
6 Measurement and test methods . 8
6.1 Test conditions .8
6.2 Visual examination .8
6.2.1 General .8
6.2.2 Interpretation of the results .9
6.3 Length .9
6.3.1 Apparatus .9
6.3.2 Method . .9
6.3.3 Interpretation of the results .9
6.4 Taper measurements .9
6.4.1 Apparatus .9
6.4.2 Method for taper of standard and greater taper points .9
6.4.3 Interpretation of the results .10
6.5 Physical integrity .10
6.5.1 General .10
6.5.2 Apparatus .10
6.5.3 Method . .10
6.5.4 Interpretation of the results .10
6.6 Radiopacity .11
6.6.1 General .11
6.6.2 Apparatus .11
6.6.3 Method . . 12
6.6.4 Interpretation of the results . 12
6.7 Melt mass-flow rate . 12
7 Product information .12
7.1 Labelling . 12
7.2 Marking . 13
7.3 Packaging . 13
7.4 Instruction for use . . 13
Annex A (normative) Melt mass-flow rate test .16
Bibliography . 19

iii
ISO 6877:2025(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee
has been established has the right to be represented on that committee. International organizations,
governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely
with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity, or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s), which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO-specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the World
Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see the following URL:
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 1, Filling and
restorative materials, in collaboration with the European Committee for Standardization (CEN) Technical
Committee CEN/TC 55, Dentistry, in accordance with the Agreement on technical cooperation between ISO
and CEN (Vienna Agreement).
This fourth edition cancels and replaces the third edition (ISO 6877:2021), which has been technically
revised.
The main changes compared to the previous edition are as follows:
— elimination of metallic points (cones);
— inclusion of tolerances d and d for standard, greater taper, and variable taper points;
3 16
— change of terminology from "numbering system" to "nominal size";
— modification of Table 1;
— addition of Table 2;
— modification of Figure 1 and Figure 2;
— inclusion of requirements to state the initial taper and its length for variable taper points;
— inclusion of requirements to state the taper and tolerances for auxiliary points;
— addition of a new normative reference;
— removal of inappropriate requirements for carrier-based obturation devices;
— modification of the carrier-based obturation device drawing.

iv
ISO 6877:2025(en)
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

v
ISO 6877:2025(en)
Introduction
The following information should be considered when using this document: specific qualitative and
quantitative test methods for demonstrating freedom from unacceptable biological risks are not included in
this document, but it is recommended that, for the assessment of such biological risks, reference be made to
ISO 7405 and ISO 10993-1. No performance limits are provided in this document for melt mass-flow rate, but
they can be added in the future.

vi
International Standard ISO 6877:2025(en)
Dentistry — Endodontic obturating materials
1 Scope
This document specifies the requirements for the dimensions of various endodontic obturating materials
and the radiopacity for polymeric points, polymeric-coated thermoplastic obturating carriers, non-point-
shaped thermoplastic obturating material, or combinations of the above used for obturation of a root
canal system. It also specifies numerical and colour-coding systems for designating the sizes of preformed
endodontic obturating points, a method for determining the melt mass-flow rate for injection material, and
the requirements for marking, labelling, packaging and the instructions for use.
Dental endodontic obturating points are marketed as sterilized or non-sterilized. Sterility is not included in
this document. Any claim that the product is sterile is the manufacturer's responsibility (see Table 3). This
document does not apply to instruments or apparatus used with obturating materials that become plastic
with heat or materials supporting a coronal restoration.
Clause 7 specifies marking, labelling and packaging, including the instructions for use. This document
does not specify requirements or test methods for sterility. Reference to applicable national regulations,
internationally accepted pharmacopoeia and standards for validating sterilization processes can apply.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
the requirements of this document. For dated references, only the edition cited applies. The latest edition of
the referenced document (including any amendments) applies for undated references.
ISO 1942, Dentistry — Vocabulary
ISO 3630-1, Dentistry — Endodontic instruments — Part 1: General requirements
ISO 3665, Photography — Intra-oral dental radiographic film and film packets — Manufacturer specifications
ISO 8601-1, Date and time — Representations for information interchange — Part 1: Basic rules
ISO 13116:2014, Dentistry — Test method for determining radio-opacity of materials
ISO 15223-1, Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part
1: General requirements
ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories
ISO 20417, Medical devices — Information to be supplied by the manufacturer
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942, ISO 3630-1 and the
following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org

ISO 6877:2025(en)
3.1
endodontic sealing material
material intended to permanently seal the root canal system usually used in combination with endodontic
obturating materials (3.2) during orthograde obturation, i.e. filling a root canal from the coronal part of a
tooth, or materials used for other endodontic sealing procedures including apexification, perforation filling,
resorption or retrograde root-end filling
Note 1 to entry: Endodontic sealing material is within the scope of ISO 6876.
3.2
endodontic obturating material
radiopaque dental material used in the form of a point (3.3), carrier-based obturating device, or injection
material used in combination with an endodontic sealing material (3.1) to fill voids and seal root canals
during orthograde obturation
3.3
point
preformed polymeric cone for use in the obturation of a root canal system, used with endodontic sealing
material (3.1)
Note 1 to entry: For the purposes of this document, the term “endodontic obturating point (cone)” is abbreviated as
“point”.
Note 2 to entry: For the purposes of this document, the term "tip" refers to the smaller end of the point (cone) inserted
towards the apex.
3.4
nominal size
D
general designation of a point (3.3), based on the size of the calculated diameter at the end of the point with
the extended taper of the point in hundredths of a millimetre
Note 1 to entry: The nominal size is described by “###” representing the size of D in hundredths of a millimetre.
Note 2 to entry: See Figure 1 for standard and greater taper points, where the determination of the nominal size is
shown. For variable taper points, the extended diameter of the initial taper is used to determine D.
Note 3 to entry: For a carrier-based obturating device, D is designated by the manufacturer. D corresponds to the final
instrument size of the root canal preparation that the manufacturer deems suitable for the nominal size, D, of the device.
3.5
taper
percentage increase in diameter from the tip to the proximal end of the point (3.3), indicated by two numbers
EXAMPLE An 02 taper represents a nominal 2 % increase in diameter from the tip to the proximal end of the point.
Note 1 to entry: The manufacturer designates the taper for a carrier-based obturating device.
3.6
standard point
point (3.3) that has a uniform 02 taper (3.5) over the first 16 mm from the tip to the proximal end of the point
3.7
greater taper point
point (3.3) that has a uniform taper (3.5) greater than 02 over the first 16 mm from the tip to the proximal
end of the point
3.8
variable taper point
point (3.3) that has multiple tapers that decrease over the first 16 mm from the tip to the proximal end of
the point
Note 1 to entry: The first taper, nearest the tip, is considered the initial taper.

ISO 6877:2025(en)
3.9
auxiliary point
point (3.3), excepting standard point (3.6), greater taper point (3.7), and variable taper point (3.8)
Note 1 to entry: Auxiliary points are not subject to nominal size (3.4) requirements.
3.10
carrier-based obturating device
thermoplastic polymeric material coated on a core or carrier material, used to obturate a root canal
Note 1 to entry: The core material can remain in the canal or can be removed after carrying the thermoplastic material
into the root canal.
Note 2 to entry: Nominal size (3.4) and taper (3.5) of a carrier-based obturating device corresponds to the final
instrument taper of the root canal preparation that the manufacturer deems suitable for the nominal size of the device.
Note 3 to entry: Carrier-based obturating devices require a heating system, which is different from an injection
system (3.12).
3.11
injection material
endodontic obturating material (3.1) supplied in non-point form, such as pellets, which become plastic after
being warmed, for injection in a root canal system
3.12
injection system
device designed to dispense warmed thermoplastic injection material (3.11) for obturation of a root canal system
3.13
melt mass-flow rate
MFR
measure of flow through a capillary of a thermoplastic injection material (3.11) at a particular temperature,
measured in grams per unit of time under a given force
Note 1 to entry: Thermoplastic materials may be placed into a root canal system using an injection system (3.12).
3.14
unit pack
smallest pack of points (3.3) distributed, containing one or more sizes of point or carrier-based obturating
device (3.10)
3.15
radiopacity
property of materials to obstruct the passage of X-rays through the material, appearing grey or white on an
exposed film or sensor image
4 Requirements
4.1 Appearance
A point shall be smooth, uniform, and free from extraneous matter throughout its length. Test in accordance
with 6.2.
4.2 Length
The overall length, l , shall be not less than 28 mm, unless otherwise stated by the manufacturer. If some
tot
other length is stated, the point shall not be less than the stated length. Test in accordance with 6.3.

ISO 6877:2025(en)
4.3 Designation and nominal size
The designations for the standard point, the greater taper point, the initial taper of a variable taper point,
and the carrier-based obturating device shall be in the form of a five-digit numerical set consisting of two
parts: ### XX, where ### corresponds to the nominal size and XX corresponds to the two significant
figures of the taper percent. The nominal size designation shall be accompanied by its specified colour or its
abbreviation.
The nominal size of the tip, D, except for auxiliary points, shall be in accordance with the numbering system
shown in Tables 1 and 2.
EXAMPLE A point of nominal size 040 and 2 % taper is designated as 040 02 and has black colour coding.
4.4 Tolerances
The tolerances of the diameters of a standard point and a greater taper point for d and d
...