The following data is part of a premarket notification filed by Sulzer Calcitek, Inc. with the FDA for Spline Dental Implant System - Spline Xi Implant.
| Device ID | K981562 |
| 510k Number | K981562 |
| Device Name: | SPLINE DENTAL IMPLANT SYSTEM - SPLINE XI IMPLANT |
| Classification | Material, Tooth Shade, Resin |
| Applicant | SULZER CALCITEK, INC. 2320 FARADAY AVE. Carlsbad, CA 92008 |
| Contact | Foster Boop |
| Correspondent | Foster Boop SULZER CALCITEK, INC. 2320 FARADAY AVE. Carlsbad, CA 92008 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-01 |
| Decision Date | 1998-07-30 |
| Summary: | summary |