PHOENIX OPTI-MAX DENT IMPL W/PLAS-SPRAY TITA/HYDRO

Implant, Endosseous, Root-form

PHOENIX DENTAL, INC.

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.

Pre-market Notification Details

Device IDK926101
510k NumberK926101
Device Name:PHOENIX OPTI-MAX DENT IMPL W/PLAS-SPRAY TITA/HYDRO
ClassificationImplant, Endosseous, Root-form
Applicant PHOENIX DENTAL, INC. 11222 WALLABY COURT San Diego,  CA  92128
ContactAlan Donald
CorrespondentAlan Donald
PHOENIX DENTAL, INC. 11222 WALLABY COURT San Diego,  CA  92128
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-12-03
Decision Date1994-06-23

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