The following data is part of a premarket notification filed by Implant Innovations International, Inc. with the FDA for Drilling Machine W/handpieces & Internal Irriga..
| Device ID | K891612 |
| 510k Number | K891612 |
| Device Name: | DRILLING MACHINE W/HANDPIECES & INTERNAL IRRIGA. |
| Classification | Amalgamator, Dental, Ac-powered |
| Applicant | IMPLANT INNOVATIONS INTERNATIONAL, INC. 1897 PALM BEACH LAKES BLVD. SUITE 114 West Palm Beach, FL 33409 |
| Contact | J Lassara |
| Correspondent | J Lassara IMPLANT INNOVATIONS INTERNATIONAL, INC. 1897 PALM BEACH LAKES BLVD. SUITE 114 West Palm Beach, FL 33409 |
| Product Code | EFD |
| CFR Regulation Number | 872.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-20 |
| Decision Date | 1989-06-12 |