ELN — Teeth, Preformed Gold Denture Class I
FDA product code ELN covers "Teeth, Preformed Gold Denture", a Class I medical device regulated under 21 CFR 872.3580. Submissions are reviewed by the Dental panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- ELN
- Device Class
- Class I
- Regulation Number
- 872.3580
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K770872 | espe gmbh (us) | IMPRESSION MATERIAL, ALGINATE | June 1, 1977 |