PERIOSRP TOOTH ROOT CONDITIONER WITH NOVAMIN

Varnish, Cavity

NOVAMIN TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Novamin Technology, Inc. with the FDA for Periosrp Tooth Root Conditioner With Novamin.

Pre-market Notification Details

Device IDK071267
510k NumberK071267
Device Name:PERIOSRP TOOTH ROOT CONDITIONER WITH NOVAMIN
ClassificationVarnish, Cavity
Applicant NOVAMIN TECHNOLOGY, INC. 13709 PROGRESS BLVD., STE. 23 Alachua,  FL  32615
ContactRobert G Rothfritz
CorrespondentRobert G Rothfritz
NOVAMIN TECHNOLOGY, INC. 13709 PROGRESS BLVD., STE. 23 Alachua,  FL  32615
Product CodeLBH  
CFR Regulation Number872.3260 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-05-07
Decision Date2007-05-18

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