The following data is part of a premarket notification filed by Implantech Associates, Inc. with the FDA for Implantech Temporal Implant.
| Device ID | K943644 |
| 510k Number | K943644 |
| Device Name: | IMPLANTECH TEMPORAL IMPLANT |
| Classification | Prosthesis, Chin, Internal |
| Applicant | IMPLANTECH ASSOCIATES, INC. 7100 HAYVENHURST AVE., SUITE 207 Van Nuys, CA 91406 |
| Contact | Edward Basile |
| Correspondent | Edward Basile IMPLANTECH ASSOCIATES, INC. 7100 HAYVENHURST AVE., SUITE 207 Van Nuys, CA 91406 |
| Product Code | FWP |
| CFR Regulation Number | 878.3550 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-27 |
| Decision Date | 1994-10-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M724TS09R1 | K943644 | 000 |
| M724TS07L1 | K943644 | 000 |
| M724TS09L1 | K943644 | 000 |
| M724TS04EL1 | K943644 | 000 |
| M724TS04ER1 | K943644 | 000 |
| M724TS04L1 | K943644 | 000 |
| M724TS06EL1 | K943644 | 000 |
| M724TS06ER1 | K943644 | 000 |
| M724TS07R1 | K943644 | 000 |
| M724TS04R1 | K943644 | 000 |