The following data is part of a premarket notification filed by Implant Innovations International, Inc. with the FDA for Abutment Glo.
Device ID | K905303 |
510k Number | K905303 |
Device Name: | ABUTMENT GLO |
Classification | Agent, Polishing, Abrasive, Oral Cavity |
Applicant | IMPLANT INNOVATIONS INTERNATIONAL, INC. 1897 PALM BEACH LAKES BLVD. SUITE 114 West Palm Beach, FL 33409 |
Contact | William O Conety |
Correspondent | William O Conety IMPLANT INNOVATIONS INTERNATIONAL, INC. 1897 PALM BEACH LAKES BLVD. SUITE 114 West Palm Beach, FL 33409 |
Product Code | EJR |
CFR Regulation Number | 872.6030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-11-28 |
Decision Date | 1991-06-10 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ABUTMENT GLO 74335801 1786450 Dead/Cancelled |
IMPLANT INNOVATIONS, INC. 1992-12-01 |