The following data is part of a premarket notification filed by Sulzer Dental, Inc. with the FDA for Sulzer Dental Ceramic System-hexlock.
| Device ID | K014175 |
| 510k Number | K014175 |
| Device Name: | SULZER DENTAL CERAMIC SYSTEM-HEXLOCK |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | SULZER DENTAL, INC. 1900 ASTON AVE. Carlsbad, CA 92008 -7308 |
| Contact | Sean Hariri |
| Correspondent | Sean Hariri SULZER DENTAL, INC. 1900 ASTON AVE. Carlsbad, CA 92008 -7308 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-20 |
| Decision Date | 2002-03-20 |
| Summary: | summary |