The following data is part of a premarket notification filed by Sulzer Calcitek, Inc. with the FDA for Spline Dental Implant System-temporary Abutment.
| Device ID | K982305 |
| 510k Number | K982305 |
| Device Name: | SPLINE DENTAL IMPLANT SYSTEM-TEMPORARY ABUTMENT |
| Classification | Implant, Endosseous, Root-form |
| 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 | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-01 |
| Decision Date | 1998-09-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024013254 | K982305 | 000 |
| 00889024013247 | K982305 | 000 |
| 00889024013230 | K982305 | 000 |
| 00889024013223 | K982305 | 000 |
| 00889024013216 | K982305 | 000 |
| 00889024013209 | K982305 | 000 |