The following data is part of a premarket notification filed by Calcitek, Inc. with the FDA for 5.0mm Spline Endosseous Dental Implant Systems.
| Device ID | K955619 |
| 510k Number | K955619 |
| Device Name: | 5.0MM SPLINE ENDOSSEOUS DENTAL IMPLANT SYSTEMS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | CALCITEK, INC. 2320 FARADAY AVE. Carlsbad, CA 92008 -7216 |
| Contact | Donna K Howard |
| Correspondent | Donna K Howard CALCITEK, INC. 2320 FARADAY AVE. Carlsbad, CA 92008 -7216 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-11 |
| Decision Date | 1996-03-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024013360 | K955619 | 000 |
| 00889024012400 | K955619 | 000 |
| 00889024012394 | K955619 | 000 |
| 00889024012387 | K955619 | 000 |
| 00889024012363 | K955619 | 000 |
| 00889024012318 | K955619 | 000 |
| 00889024012301 | K955619 | 000 |
| 00889024012295 | K955619 | 000 |
| 00889024012288 | K955619 | 000 |
| 00889024011700 | K955619 | 000 |
| 00889024011717 | K955619 | 000 |
| 00889024013339 | K955619 | 000 |
| 00889024012547 | K955619 | 000 |
| 00889024012530 | K955619 | 000 |
| 00889024012103 | K955619 | 000 |
| 00889024012028 | K955619 | 000 |
| 00889024012011 | K955619 | 000 |
| 00889024012004 | K955619 | 000 |
| 00889024011724 | K955619 | 000 |
| 00889024012264 | K955619 | 000 |