The following data is part of a premarket notification filed by Sulzer Calcitek, Inc. with the FDA for Threadloc Dental Implant Systems.
| Device ID | K964768 |
| 510k Number | K964768 |
| Device Name: | THREADLOC DENTAL IMPLANT SYSTEMS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | SULZER CALCITEK, INC. 2320 FARADAY AVE. Carlsbad, CA 92008 |
| Contact | Joseph S Shan |
| Correspondent | Joseph S Shan SULZER CALCITEK, INC. 2320 FARADAY AVE. Carlsbad, CA 92008 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-27 |
| Decision Date | 1997-02-25 |
| Summary: | summary |