SCREW IMPLANTS, GRADE 3; UNCOATED, HA, TP-K3

Implant, Endosseous, Root-form

THE IMPLANT CENTER OF THE PALM BEACHES

The following data is part of a premarket notification filed by The Implant Center Of The Palm Beaches with the FDA for Screw Implants, Grade 3; Uncoated, Ha, Tp-k3.

Pre-market Notification Details

Device IDK953235
510k NumberK953235
Device Name:SCREW IMPLANTS, GRADE 3; UNCOATED, HA, TP-K3
ClassificationImplant, Endosseous, Root-form
Applicant THE IMPLANT CENTER OF THE PALM BEACHES 824 U.S HIGHWAY 1 SUITE 370 North Palm Beach,  FL  33408
ContactJack T Krauser
CorrespondentJack T Krauser
THE IMPLANT CENTER OF THE PALM BEACHES 824 U.S HIGHWAY 1 SUITE 370 North Palm Beach,  FL  33408
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-07-11
Decision Date1995-09-13

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