ISO 6877-2025 PDF

Full title and description

St ISO 6877-2025 — Dentistry — Endodontic obturating materials. This International Standard specifies dimensional, radiopacity and related requirements for preformed and thermoplastic endodontic obturating materials, size-designation systems and requirements for marking, labelling, packaging and instructions for use; sterility is not specified.

Abstract

ISO 6877:2025 establishes requirements and test-method references for various endodontic obturating materials (polymeric points, polymeric‑coated thermoplastic carriers, non‑point thermoplastic materials and combinations). It includes size coding (numerical and colour), a method for determining melt mass‑flow rate for injection materials, radiopacity limits for polymeric points and provisions for marking, labelling, packaging and instructions for use. The document excludes requirements for sterility and does not apply to instruments or apparatus used with heat‑plasticized obturating materials.

General information

• Status: Published.
• Publication date: August 2025.
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.060.10 (Dentistry).
• Edition / version: Edition 4 (ISO 6877:2025).
• Number of pages: 19 pages.

Scope

This standard applies to preformed and thermoplastic obturating materials intended for obturation of the root‑canal system. It specifies dimensional requirements, radiopacity limits (for polymeric points and related products), a melt mass‑flow‑rate method for injection materials, size designation systems (numerical and colour coding), and marking/packaging/instruction requirements. It does not set requirements for sterility and excludes instruments or apparatus intended for use with heat‑plasticized obturating materials or materials intended to support coronal restorations.

Key topics and requirements

• Dimensional specifications for preformed obturating points and non‑point thermoplastic materials.
• Radiopacity requirements for polymeric points and polymeric‑coated carriers.
• Numerical and colour‑coding systems for size designation of preformed points.
• Method for determining melt mass‑flow rate of injection (thermoplastic) obturating materials.
• Requirements for marking, labelling, packaging and instructions for use (including declaration of relevant product claims); sterility claims are the manufacturer's responsibility and sterilization validation standards are referenced elsewhere.
• Exclusions and clarifications: sterility not specified; not intended for coronal‑restoration support or for instruments/apparatus used with heat‑softened materials.

Typical use and users

Primary users include dental‑material manufacturers (product design, quality control and labelling), dental laboratories, test and certification bodies, regulatory authorities reviewing product compliance, dental clinicians and procurement specialists who need to confirm product sizing and radiopacity characteristics for endodontic practice. Standards committees and test laboratories will use the document to harmonize test methods and interpretation.

Related standards

Closely related endodontic standards include ISO 6876 (Dentistry — Endodontic sealing materials), which covers sealers and complementary requirements and has been revised in the same standards family; standards addressing sterilization validation (for manufacturers claiming sterility) such as ISO 11737 series are also relevant for manufacturers. National and regional adoptions (EN/UNE/ST) of ISO 6877 may exist.

Keywords

endodontic, obturating materials, root canal, polymeric points, thermoplastic obturating material, radiopacity, size coding, melt mass‑flow rate, labelling, packaging, dentistry standards.

FAQ

Q: What is this standard?

A: ISO 6877:2025 is an International Standard specifying requirements and test‑method references for endodontic obturating materials (preformed points and thermoplastic obturating materials), including dimensions, radiopacity and size designation systems.

Q: What does it cover?

A: It covers dimensional requirements, radiopacity for polymeric products, numerical and colour coding for sizes, a melt mass‑flow‑rate method for injection materials, and marking/label, packaging and instructions for use. It does not define sterility requirements and excludes instruments used with heat‑plasticized materials.

Q: Who typically uses it?

A: Manufacturers of endodontic obturating materials, testing laboratories, conformity assessment bodies, dental clinicians selecting products, and regulatory bodies reviewing product claims and labelling.

Q: Is it current or superseded?

A: ISO 6877:2025 is the current published edition (Edition 4, published August 2025). Previous editions (for example ISO 6877:2021 and earlier) have been withdrawn and replaced by this 2025 edition.

Q: Is it part of a series?

A: Yes — it belongs to the ISO dentistry/endodontic family of standards maintained by ISO/TC 106/SC 1. Related standards within this family include ISO 6876 (endodontic sealing materials) and sterilization/validation standards (ISO 11737 series) that manufacturers may need to consult.

Q: What are the key keywords?

A: Key keywords are endodontic obturating materials, obturation points, thermoplastic obturating, radiopacity, size coding, melt mass‑flow rate, labelling, packaging, dentistry.