The following data is part of a premarket notification filed by Sulzer Dental, Inc. with the FDA for Hex-lock Temporary Abutment.
| Device ID | K014050 |
| 510k Number | K014050 |
| Device Name: | HEX-LOCK TEMPORARY ABUTMENT |
| Classification | Implant, Endosseous, Root-form |
| 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 | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-10 |
| Decision Date | 2002-11-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024014633 | K014050 | 000 |
| 00889024330825 | K014050 | 000 |
| 00889024330818 | K014050 | 000 |
| 00889024330801 | K014050 | 000 |