The following data is part of a premarket notification filed by Impla-med with the FDA for Titanium/stainless Steel Instruments.
| Device ID | K902911 |
| 510k Number | K902911 |
| Device Name: | TITANIUM/STAINLESS STEEL INSTRUMENTS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | IMPLA-MED 13794 N.W. 4TH ST. SUITE 209 Sunrise, FL 33325 |
| Contact | Smolowitz |
| Correspondent | Smolowitz IMPLA-MED 13794 N.W. 4TH ST. SUITE 209 Sunrise, FL 33325 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-02 |
| Decision Date | 1990-09-06 |