HA, TP CYLINDER, UNIHOLE

Implant, Endosseous, Root-form

IMPLANT CENTER OF THE PALM BEACHES

The following data is part of a premarket notification filed by Implant Center Of The Palm Beaches with the FDA for Ha, Tp Cylinder, Unihole.

Pre-market Notification Details

Device IDK953280
510k NumberK953280
Device Name:HA, TP CYLINDER, UNIHOLE
ClassificationImplant, Endosseous, Root-form
Applicant IMPLANT CENTER OF THE PALM BEACHES 824 US HWY I, STE. 370 N. Palm Beach,  FL  33408
ContactJack T Krauser
CorrespondentJack T Krauser
IMPLANT CENTER OF THE PALM BEACHES 824 US HWY I, STE. 370 N. Palm Beach,  FL  33408
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-07-13
Decision Date1995-09-15

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