The following data is part of a premarket notification filed by Lifecore Biomedical, Inc. with the FDA for Stage- 1 Temporary/healing Cap, Model 42021-42026.
| Device ID | K053643 |
| 510k Number | K053643 |
| Device Name: | STAGE- 1 TEMPORARY/HEALING CAP, MODEL 42021-42026 |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | LIFECORE BIOMEDICAL, INC. 3515 LYMAN BLVD. Chaska, MN 55318 -3015 |
| Contact | Brian Smekal |
| Correspondent | Brian Smekal LIFECORE BIOMEDICAL, INC. 3515 LYMAN BLVD. Chaska, MN 55318 -3015 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-30 |
| Decision Date | 2006-01-23 |
| Summary: | summary |