| ISO 6877 Second edition 2006-04-01 Dentistry - Root-canal obturating points |
| Recognition Date | 2014-01-30 |
| Recognition List | 034 |
| Recognition Number | 4-137 |
| 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 the dimensions and compositional requirements for prefabricated metal or polymeric points or cones suitable for use in the obturation of the dental root-canal, but not for support of a coronal restoration. It also specifies numerical systems and a colour coding system for designating the s....
Dental root-canal obturating points are marketed sterilized or unsterilized. This International Standard covers the physical attributes expected of such products as supplied. Requirements for sterility are not included, and any claim that the product is sterile is the responsibility of the manufacturer...
| Regulation Number | Device Name | Device Class | Product Code |
| §872.3850 | Gutta-Percha | Class 1 | EKM |
| §872.3840 | Point, Silver, Endodontic | Class 1 | EKL |
| §872.3820 | Resin, Root Canal Filling | Class 2 | KIF |
| There is no relevant guidance developed at this time. |