ORALIEF OTC TOOTHPASTE FOR SENSITIVE TEETH

Varnish, Cavity

NOVAMIN TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Novamin Technology, Inc. with the FDA for Oralief Otc Toothpaste For Sensitive Teeth.

Pre-market Notification Details

Device IDK080228
510k NumberK080228
Device Name:ORALIEF OTC TOOTHPASTE FOR SENSITIVE TEETH
ClassificationVarnish, Cavity
Applicant NOVAMIN TECHNOLOGY, INC. 13859 PROGRESS BLVD.,#600 Alachua,  FL  32615
ContactRobert G Rothfritz
CorrespondentRobert G Rothfritz
NOVAMIN TECHNOLOGY, INC. 13859 PROGRESS BLVD.,#600 Alachua,  FL  32615
Product CodeLBH  
CFR Regulation Number872.3260 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-01-30
Decision Date2008-03-27
Summary:summary

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