Recognized standard
16498 First edition 2013-07 Standard No. 172-2019
FDA recognition 4-391 · ISO · Dental/ENT
Key facts
| Recognition number | 4-391 |
|---|---|
| Designation | 16498 First edition 2013-07 Standard No. 172-2019 |
| Title | Dentistry - Minimal dental implant data set for clinical use Minimal Dental Implant Data Set for Clinical Use |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | May 25, 2026 |
| Device classes | Class 2 |
| Scope (excerpt) | ISO 16498:2013 specifies the minimal data set to be recorded for a patient receiving dental implant treatment. This will comprise the locations and types of dental implant bodies, connecting components and adjunctive devices, including grafting materials, placed in a patient's jaw(s). |
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: