The following data is part of a premarket notification filed by Implant Innovations, Inc. with the FDA for Conical Abutment.
Device ID | K933462 |
510k Number | K933462 |
Device Name: | CONICAL ABUTMENT |
Classification | Implant, Endosseous, Root-form |
Applicant | IMPLANT INNOVATIONS, INC. 3071 CONTINENTAL DR. West Palm Beach, FL 33407 |
Contact | William G Conety |
Correspondent | William G Conety IMPLANT INNOVATIONS, INC. 3071 CONTINENTAL DR. West Palm Beach, FL 33407 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-07-16 |
Decision Date | 1994-03-07 |