CUSTOM COMFORT NIGHTGUARD VERSION 2

Mouthguard, Over-the-counter

DENTEK ORAL CARE, INC.

The following data is part of a premarket notification filed by Dentek Oral Care, Inc. with the FDA for Custom Comfort Nightguard Version 2.

Pre-market Notification Details

Device IDK091660
510k NumberK091660
Device Name:CUSTOM COMFORT NIGHTGUARD VERSION 2
ClassificationMouthguard, Over-the-counter
Applicant DENTEK ORAL CARE, INC. 555 THIRTEENTH STREET, NW Washington,  DC  20004
ContactHoward M Holstein
CorrespondentHoward M Holstein
DENTEK ORAL CARE, INC. 555 THIRTEENTH STREET, NW Washington,  DC  20004
Product CodeOBR  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-06-09
Decision Date2009-06-12
Summary:summary

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