The following data is part of a premarket notification filed by Lifecore Biomedical, Inc. with the FDA for Primaconnex Ceramic Abutments.
| Device ID | K062876 |
| 510k Number | K062876 |
| Device Name: | PRIMACONNEX CERAMIC ABUTMENTS |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | LIFECORE BIOMEDICAL, INC. 3515 LYMAN BLVD. Chaska, MN 55318 |
| Contact | Brian Smekal |
| Correspondent | Brian Smekal LIFECORE BIOMEDICAL, INC. 3515 LYMAN BLVD. Chaska, MN 55318 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-26 |
| Decision Date | 2006-11-01 |
| Summary: | summary |