CLEAN AND BOOST

Agent, Tooth Bonding, Resin

APEX DENTAL MATERIALS, INC.

The following data is part of a premarket notification filed by Apex Dental Materials, Inc. with the FDA for Clean And Boost.

Pre-market Notification Details

Device IDK120620
510k NumberK120620
Device Name:CLEAN AND BOOST
ClassificationAgent, Tooth Bonding, Resin
Applicant APEX DENTAL MATERIALS, INC. 330 TELSER ROAD Lake Zurich,  IL  60047
ContactChris Kulton
CorrespondentChris Kulton
APEX DENTAL MATERIALS, INC. 330 TELSER ROAD Lake Zurich,  IL  60047
Product CodeKLE  
CFR Regulation Number872.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-03-01
Decision Date2012-05-31

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850194007312 K120620 000
00850194007305 K120620 000
00850194007299 K120620 000
00850194007282 K120620 000
00850194007961 K120620 000
00850194007954 K120620 000
00850194007794 K120620 000
00850194007787 K120620 000

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