The following data is part of a premarket notification filed by Lifecore Biomedical, Inc. with the FDA for Regular Diameter Single Stage (rds) Tps Dental Implant System.
| Device ID | K991114 |
| 510k Number | K991114 |
| Device Name: | REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | LIFECORE BIOMEDICAL, INC. 3515 LYMAN BLVD. Chaska, MN 55318 |
| Contact | Carolyn Anderson |
| Correspondent | Carolyn Anderson 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 | 1999-04-01 |
| Decision Date | 1999-07-14 |
| Summary: | summary |