The following data is part of a premarket notification filed by L.a.k. Ent., Inc. with the FDA for Preformed Dental Impression Trays.
| Device ID | K850776 |
| 510k Number | K850776 |
| Device Name: | PREFORMED DENTAL IMPRESSION TRAYS |
| Classification | Tray, Impression, Preformed |
| Applicant | L.A.K. ENT., INC. BELLSEY & BAKER 100 CALIFORNIA STREET #460 San Francisco, CA 94111 |
| Contact | Steven W Baker |
| Correspondent | Steven W Baker L.A.K. ENT., INC. BELLSEY & BAKER 100 CALIFORNIA STREET #460 San Francisco, CA 94111 |
| Product Code | EHY |
| CFR Regulation Number | 872.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-26 |
| Decision Date | 1985-03-18 |