The following data is part of a premarket notification filed by Calcitek, Inc. with the FDA for Integral Vii 4.9mm Biointegrated Dental Implant System.
| Device ID | K946319 |
| 510k Number | K946319 |
| Device Name: | INTEGRAL VII 4.9MM BIOINTEGRATED DENTAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | CALCITEK, INC. 2320 FARADAY AVE. Carlsbad, CA 92008 -7216 |
| Contact | Carol White |
| Correspondent | Carol White 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 | 1994-12-28 |
| Decision Date | 1995-11-15 |