The following data is part of a premarket notification filed by Lifecore Biomedical, Inc. with the FDA for Primaconnex Cad/cam Abutment System.
| Device ID | K072241 |
| 510k Number | K072241 |
| Device Name: | PRIMACONNEX CAD/CAM ABUTMENT SYSTEM |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | LIFECORE BIOMEDICAL, INC. 3515 LYMAN BLVD. Chaska, MN 55318 |
| Contact | Judith Medlock-hayes |
| Correspondent | Judith Medlock-hayes LIFECORE BIOMEDICAL, INC. 3515 LYMAN BLVD. Chaska, MN 55318 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-13 |
| Decision Date | 2007-11-09 |
| Summary: | summary |