KIS-II IMPLANT FIXTURES

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 Kis-ii Implant Fixtures.

Pre-market Notification Details

Device IDK943971
510k NumberK943971
Device Name:KIS-II IMPLANT FIXTURES
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 Received1994-08-15
Decision Date1995-03-01

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