The following data is part of a premarket notification filed by Sulzer Dental, Inc. with the FDA for Taper-lock Dental Implant System.
| Device ID | K011038 |
| 510k Number | K011038 |
| Device Name: | TAPER-LOCK DENTAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | SULZER DENTAL, INC. 1900 ASTON AVE. Carlsbad, CA 92008 -7308 |
| Contact | Diana Smith |
| Correspondent | Diana Smith 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 | 2001-04-05 |
| Decision Date | 2001-05-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024014947 | K011038 | 000 |
| 00889024014930 | K011038 | 000 |
| 00889024013643 | K011038 | 000 |
| 00889024020320 | K011038 | 000 |
| 00889024018600 | K011038 | 000 |