The following data is part of a premarket notification filed by Dentca, Inc. with the FDA for Dentca Denture Base.
| Device ID | K143033 |
| 510k Number | K143033 |
| Device Name: | DENTCA DENTURE BASE |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | DENTCA, INC. 3608 Griffith Avenue Los Angeles, CA 90011 |
| Contact | Jason Lee |
| Correspondent | Claude Berthoin DENTERPRISE INTERNATIONAL, INC. 110 EAST GRANADA BLVD SUITE 207 Ormond Beach, FL 32176 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-22 |
| Decision Date | 2015-07-21 |
| Summary: | summary |