| ISO 6876 Third edition 2012-06-01 Dentistry -- Root canal sealing materials |
| Recognition Date | 2014-01-30 |
| Recognition List | 034 |
| Recognition Number | 4-199 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | Dental/ENT |
| FDA Tech | Michael Adjodha FDA/OMPT/CDRH/ODE/DAGID/DEDB 301-796-6276 michael.adjodha@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
This International Standard specifies requirements and test methods for root canal (endodontic) sealing materials which set with or without the assistance of moisture and are used for permanent obturation of the root canal with or without the aid of obturating points/cones. It only covers sealers intended for orthograde use i.e. a root filling placed from the coronal aspect of a tooth.
| Regulation Number | Device Name | Device Class | Product Code |
| §872.3820 | Resin, Root Canal Filling | Class 2 | KIF |
| There is no relevant guidance developed at this time. |