The following data is part of a premarket notification filed by Lifecore Biomedical, Inc. with the FDA for Restore Tps Lhex Cylinder Endosseous Implant System.
| Device ID | K944069 |
| 510k Number | K944069 |
| Device Name: | RESTORE TPS LHEX CYLINDER ENDOSSEOUS IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | LIFECORE BIOMEDICAL, INC. 3515 LYMAN BLVD. Chaska, MN 55318 |
| Contact | Lynn C Uperus |
| Correspondent | Lynn C Uperus LIFECORE BIOMEDICAL, INC. 3515 LYMAN BLVD. Chaska, MN 55318 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-18 |
| Decision Date | 1995-02-28 |