Recognized standard
13504 First edition 2012-07
FDA recognition 4-307 · ISO · Dental/ENT
Key facts
| Recognition number | 4-307 |
|---|---|
| Designation | 13504 First edition 2012-07 |
| Title | Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | May 29, 2023 |
| Device classes | Class 1 |
| Scope (excerpt) | ISO 13504:2012 specifies general requirements for the manufacture of instruments and related accessories used in the placement of dental implants and further manipulations of connecting parts in the craniofacial area. It is applicable to single-use and reusable instruments, regardless of whether… |
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: