The following data is part of a premarket notification filed by Biohorizons Implant Systems, Inc. with the FDA for Implant Site Dilators.
| Device ID | K980374 |
| 510k Number | K980374 |
| Device Name: | IMPLANT SITE DILATORS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | BIOHORIZONS IMPLANT SYSTEMS, INC. 2129 MONTGOMERY WAY Birmingham, AL 35209 |
| Contact | Winston Greer |
| Correspondent | Winston Greer BIOHORIZONS IMPLANT SYSTEMS, INC. 2129 MONTGOMERY WAY Birmingham, AL 35209 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-30 |
| Decision Date | 1998-03-04 |
| Summary: | summary |