The following data is part of a premarket notification filed by Lifecore Biomedical, Inc. with the FDA for Ha-biontegrated Dental Implant Systems.
| Device ID | K914137 |
| 510k Number | K914137 |
| Device Name: | HA-BIONTEGRATED DENTAL IMPLANT SYSTEMS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | LIFECORE BIOMEDICAL, INC. 3515 LYMAN BLVD. Chaska, MN 55318 |
| Contact | Deborah L Jensen |
| Correspondent | Deborah L Jensen 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 | 1991-09-16 |
| Decision Date | 1994-02-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D7681103K0 | K914137 | 000 |
| D76811002K0 | K914137 | 000 |
| D76811004K0 | K914137 | 000 |
| D76811006K0 | K914137 | 000 |
| D76811007K0 | K914137 | 000 |
| D76811008K0 | K914137 | 000 |
| D76811009K0 | K914137 | 000 |
| D76811010K0 | K914137 | 000 |
| D76811012K0 | K914137 | 000 |
| D76811013K0 | K914137 | 000 |
| D76811014K0 | K914137 | 000 |
| D76811015K0 | K914137 | 000 |
| D76811016K0 | K914137 | 000 |
| D76811019K0 | K914137 | 000 |
| D76811020K0 | K914137 | 000 |
| D76811021K0 | K914137 | 000 |
| D76811001K0 | K914137 | 000 |