The following data is part of a premarket notification filed by Dentca, Inc. with the FDA for Dentca Base Premium, Dentca Base Hi-impact.
| Device ID | K220042 |
| 510k Number | K220042 |
| Device Name: | Dentca Base Premium, Dentca Base Hi-Impact |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | Dentca, Inc. 357 Van Ness Way, Ste 250 Torrance, CA 90501 |
| Contact | Jason Lee |
| Correspondent | Jason Lee Dentca, Inc. 357 Van Ness Way, Ste 250 Torrance, CA 90501 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-05 |
| Decision Date | 2022-11-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856551007599 | K220042 | 000 |
| 00856551007582 | K220042 | 000 |
| 00856551007575 | K220042 | 000 |
| 00856551007568 | K220042 | 000 |
| 00856551007551 | K220042 | 000 |
| 00856551007544 | K220042 | 000 |
| 00856551007537 | K220042 | 000 |
| 00856551007520 | K220042 | 000 |