Recognized standard
6876 Third edition 2012-06-01
FDA recognition 4-199 · ISO · Dental/ENT
Key facts
| Recognition number | 4-199 |
|---|---|
| Designation | 6876 Third edition 2012-06-01 |
| Title | Dentistry -- Root canal sealing materials |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | Jan 30, 2014 |
| Device classes | Class 2 |
| Scope (excerpt) | 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… |
At a glance
- 1–9 Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: