PZY — Additively Manufactured, Preformed, Resin Denture Tooth Class II
FDA product code PZY covers "Additively Manufactured, Preformed, Resin Denture Tooth", a Class II medical device regulated under 21 CFR 872.3590. 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
- PZY
- Device Class
- Class II
- Regulation Number
- 872.3590
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Definition
For the fabrication of preformed denture teeth for use in a denture base
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K172398 | dentca | DENTCA DENTURE Teeth | November 22, 2017 |