The following data is part of a premarket notification filed by Phoenix Dental, Inc. with the FDA for Phoenix Opti-max Dent Impl W/plas-spray Tita/hydro.
Device ID | K926101 |
510k Number | K926101 |
Device Name: | PHOENIX OPTI-MAX DENT IMPL W/PLAS-SPRAY TITA/HYDRO |
Classification | Implant, Endosseous, Root-form |
Applicant | PHOENIX DENTAL, INC. 11222 WALLABY COURT San Diego, CA 92128 |
Contact | Alan Donald |
Correspondent | Alan Donald PHOENIX DENTAL, INC. 11222 WALLABY COURT San Diego, CA 92128 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-03 |
Decision Date | 1994-06-23 |