510(k) K172398
K172398 is an FDA 510(k) premarket notification submitted by Dentca, Inc. for the device "DENTCA DENTURE Teeth". The FDA issued a decision of Substantially Equivalent on November 22, 2017. The device falls under product code PZY (Additively Manufactured, Preformed, Resin Denture Tooth), a Class II device regulated under 21 CFR 872.3590. Dentca, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 22, 2017
- Date Received
- August 8, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Additively Manufactured, Preformed, Resin Denture Tooth
- Device Class
- Class II
- Regulation Number
- 872.3590
- Review Panel
- DE
- Submission Type
For the fabrication of preformed denture teeth for use in a denture base