The following data is part of a premarket notification filed by Calcitek, Inc. with the FDA for Integral Plus Biointegrated Dental Implant System.
| Device ID | K900549 |
| 510k Number | K900549 |
| Device Name: | INTEGRAL PLUS BIOINTEGRATED DENTAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | CALCITEK, INC. 2320 FARADAY AVE. Carlsbad, CA 92008 -7216 |
| Contact | M Carlson |
| Correspondent | M Carlson 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 | 1990-02-05 |
| Decision Date | 1990-06-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024011380 | K900549 | 000 |
| 00889024010857 | K900549 | 000 |
| 00889024010864 | K900549 | 000 |
| 00889024010871 | K900549 | 000 |
| 00889024010901 | K900549 | 000 |
| 00889024010918 | K900549 | 000 |
| 00889024011045 | K900549 | 000 |
| 00889024011052 | K900549 | 000 |
| 00889024011069 | K900549 | 000 |
| 00889024011076 | K900549 | 000 |
| 00889024011137 | K900549 | 000 |
| 00889024011168 | K900549 | 000 |
| 00889024011175 | K900549 | 000 |
| 00889024011182 | K900549 | 000 |
| 00889024011199 | K900549 | 000 |
| 00889024011243 | K900549 | 000 |
| 00889024011250 | K900549 | 000 |
| 00889024011267 | K900549 | 000 |
| 00889024011236 | K900549 | 000 |