K172398 is an FDA 510(k) clearance for the DENTCA DENTURE Teeth. This device is classified as a Additively Manufactured, Preformed, Resin Denture Tooth (Class II - Special Controls, product code PZY).
Submitted by Dentca, Inc. (Torrance, US). The FDA issued a Cleared decision on November 22, 2017, 106 days after receiving the submission on August 8, 2017.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3590. For The Fabrication Of Preformed Denture Teeth For Use In A Denture Base.
| 510(k) Number | K172398 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 08, 2017 |
| Decision Date | November 22, 2017 |
| Days to Decision | 106 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | PZY - Additively Manufactured, Preformed, Resin Denture Tooth |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3590 |
| Definition | For The Fabrication Of Preformed Denture Teeth For Use In A Denture Base |