ORALIEF THERAPY 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 Therapy For Sensitive Teeth.

Pre-market Notification Details

Device IDK040858
510k NumberK040858
Device Name:ORALIEF THERAPY FOR SENSITIVE TEETH
ClassificationVarnish, Cavity
Applicant NOVAMIN TECHNOLOGY, INC. 13709 PROGRESS BLVD., BOX #23 Alachua,  FL  32615
ContactDavid C Greenspan
CorrespondentDavid C Greenspan
NOVAMIN TECHNOLOGY, INC. 13709 PROGRESS BLVD., BOX #23 Alachua,  FL  32615
Product CodeLBH  
CFR Regulation Number872.3260 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-04-02
Decision Date2004-09-02
Summary:summary

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