Recognized standard
6877 Second edition 2006-04-01 Standard No. 78-2013
FDA recognition 4-137 · ISO · Dental/ENT
Key facts
| Recognition number | 4-137 |
|---|---|
| Designation | 6877 Second edition 2006-04-01 Standard No. 78-2013 |
| Title | Dentistry - Root-canal obturating points Dental obturating cones |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | Jan 30, 2014 |
| Device classes | Class 2, Class 1 |
| Scope (excerpt) | 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… |
At a glance
- None 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: