The following data is part of a premarket notification filed by Dentca, Inc. with the FDA for Dentca Crown And Bridge.
| Device ID | K192806 |
| 510k Number | K192806 |
| Device Name: | DENTCA Crown And Bridge |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | Dentca, Inc. 357 Van Ness Way #250 Torrance, CA 90501 |
| Contact | Jason Lee |
| Correspondent | Joyce St. Germain The 510k Consulting, LLC 1449 Springleaf Dr Ormond Beach, FL 32174 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-01 |
| Decision Date | 2020-02-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856551007469 | K192806 | 000 |
| 00856551007049 | K192806 | 000 |
| 00856551007056 | K192806 | 000 |
| 00856551007063 | K192806 | 000 |
| 00856551007070 | K192806 | 000 |
| 00856551007087 | K192806 | 000 |
| 00856551007094 | K192806 | 000 |
| 00856551007407 | K192806 | 000 |
| 00856551007414 | K192806 | 000 |
| 00856551007421 | K192806 | 000 |
| 00856551007438 | K192806 | 000 |
| 00856551007445 | K192806 | 000 |
| 00856551007452 | K192806 | 000 |
| 00856551007032 | K192806 | 000 |