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 |