ASCENT PORCELAIN PRIMER, MODEL 006-00078, 00600079

Agent, Tooth Bonding, Resin

CAO GROUP, INC.

The following data is part of a premarket notification filed by Cao Group, Inc. with the FDA for Ascent Porcelain Primer, Model 006-00078, 00600079.

Pre-market Notification Details

Device IDK091300
510k NumberK091300
Device Name:ASCENT PORCELAIN PRIMER, MODEL 006-00078, 00600079
ClassificationAgent, Tooth Bonding, Resin
Applicant CAO GROUP, INC. 4628 WEST SKYHAWK DRIVE West Jordan,  UT  84084
ContactRobert Larson
CorrespondentRobert Larson
CAO GROUP, INC. 4628 WEST SKYHAWK DRIVE West Jordan,  UT  84084
Product CodeKLE  
CFR Regulation Number872.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-05-04
Decision Date2009-07-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00872320003272 K091300 000
00872320000509 K091300 000

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