The following data is part of a premarket notification filed by Sulzer Calcitek, Inc. with the FDA for Spline Dental Implant System.
| Device ID | K010073 |
| 510k Number | K010073 |
| Device Name: | SPLINE DENTAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | SULZER CALCITEK, INC. 1900 ASTON AVE. Carlsbad, CA 92008 -7308 |
| Contact | Foster Boop |
| Correspondent | Foster Boop SULZER CALCITEK, INC. 1900 ASTON AVE. Carlsbad, CA 92008 -7308 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-09 |
| Decision Date | 2001-01-19 |