The following data is part of a premarket notification filed by Dentca, Inc. with the FDA for Dentca Denture Teeth.
| Device ID | K172398 |
| 510k Number | K172398 |
| Device Name: | DENTCA DENTURE Teeth |
| Classification | Additively Manufactured, Preformed, Resin Denture Tooth |
| Applicant | DENTCA, INC. 357 Van Ness Way, Suite 250 Torrance, CA 90501 |
| Contact | Jason Lee |
| Correspondent | Joyce St. Germain DENTERPRISE INTERNATIONAL, INC. 100 East Granada Blvd., Suite 219 Ormond Beach, FL 32176 |
| Product Code | PZY |
| CFR Regulation Number | 872.3590 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-08 |
| Decision Date | 2017-11-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856551007353 | K172398 | 000 |
| 00856551007346 | K172398 | 000 |
| 00856551007339 | K172398 | 000 |
| 00856551007322 | K172398 | 000 |
| 00856551007315 | K172398 | 000 |
| 00856551007308 | K172398 | 000 |