The following data is part of a premarket notification filed by Dentca, Inc. with the FDA for Dentca Denture Base Ii.
| Device ID | K162044 |
| 510k Number | K162044 |
| Device Name: | Dentca Denture Base II |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | DENTCA, Inc. 357 Van Ness Way #250 Torrance, CA 90501 |
| Contact | Jason Lee |
| Correspondent | Claude Berthoin Denterprise International, Inc. 100 East Granada Blvd., Suite 219 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 | 2016-07-25 |
| Decision Date | 2017-03-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856551007278 | K162044 | 000 |
| J01466075560 | K162044 | 000 |
| 00810002220128 | K162044 | 000 |
| 00856551007001 | K162044 | 000 |
| 00856551007209 | K162044 | 000 |
| 00856551007216 | K162044 | 000 |
| 00856551007230 | K162044 | 000 |
| 00856551007247 | K162044 | 000 |
| 00856551007254 | K162044 | 000 |
| 00856551007261 | K162044 | 000 |
| J01466075558 | K162044 | 000 |