The following data is part of a premarket notification filed by Lifecore Biomedical, Inc. with the FDA for Sustain Hex Ha-coated Cylinder Endosseous Implant System.
| Device ID | K941554 |
| 510k Number | K941554 |
| Device Name: | SUSTAIN HEX HA-COATED CYLINDER ENDOSSEOUS IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | LIFECORE BIOMEDICAL, INC. 3515 LYMAN BLVD. Chaska, MN 55318 |
| Contact | Lynn Cuperus |
| Correspondent | Lynn 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 | 1994-03-30 |
| Decision Date | 1994-07-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D7684107204K0 | K941554 | 000 |
| D768410475340K0 | K941554 | 000 |
| D768410475320K0 | K941554 | 000 |
| D768410440330K0 | K941554 | 000 |
| D7684102004730K0 | K941554 | 000 |
| D7684102003330K0 | K941554 | 000 |
| D76841060545K0 | K941554 | 000 |
| D76841060535K0 | K941554 | 000 |