The following data is part of a premarket notification filed by Lifecore Biomedical, Inc. with the FDA for Primaconnex Sd Esthetic Contour Zi Abutments.
| Device ID | K073032 |
| 510k Number | K073032 |
| Device Name: | PRIMACONNEX SD ESTHETIC CONTOUR ZI ABUTMENTS |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-26 |
| Decision Date | 2007-11-16 |
| Summary: | summary |