The following data is part of a premarket notification filed by Lifecore Biomedical, Inc. with the FDA for Ha- And Tps- Restore Self Tapping Dental Implant System.
| Device ID | K950624 |
| 510k Number | K950624 |
| Device Name: | HA- AND TPS- RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | LIFECORE BIOMEDICAL, INC. 3515 LYMAN BLVD. Chaska, MN 55318 |
| Contact | Lynnn Cuperus |
| Correspondent | Lynnn Cuperus 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 | 1995-02-10 |
| Decision Date | 1995-08-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D768TS5013K0 | K950624 | 000 |
| D768TS3813UK0 | K950624 | 000 |
| D768TS3813K0 | K950624 | 000 |
| D768TS3811UK0 | K950624 | 000 |
| D768TS3811K0 | K950624 | 000 |
| D768TS3810UK0 | K950624 | 000 |
| D768TS3810K0 | K950624 | 000 |
| D768TS3808K0 | K950624 | 000 |
| D768TS3315K0 | K950624 | 000 |
| D768TS3313K0 | K950624 | 000 |
| D768TS3311UK0 | K950624 | 000 |
| D768TS3311K0 | K950624 | 000 |
| D768TS3815K0 | K950624 | 000 |
| D768TS3815UK0 | K950624 | 000 |
| D768TS5011K0 | K950624 | 000 |
| D768TS5010K0 | K950624 | 000 |
| D768TS4015UK0 | K950624 | 000 |
| D768TS4015K0 | K950624 | 000 |
| D768TS4013UK0 | K950624 | 000 |
| D768TS4013K0 | K950624 | 000 |
| D768TS4011UK0 | K950624 | 000 |
| D768TS4011K0 | K950624 | 000 |
| D768TS4010UK0 | K950624 | 000 |
| D768TS4010K0 | K950624 | 000 |
| D768TS4008K0 | K950624 | 000 |
| D768TS3310K0 | K950624 | 000 |