ACRYLIC HERBST APPLIANCE

Device, Anti-snoring

EMBASSY DENTAL LABORATORY

The following data is part of a premarket notification filed by Embassy Dental Laboratory with the FDA for Acrylic Herbst Appliance.

Pre-market Notification Details

Device IDK111009
510k NumberK111009
Device Name:ACRYLIC HERBST APPLIANCE
ClassificationDevice, Anti-snoring
Applicant EMBASSY DENTAL LABORATORY 8202 SHERMAN ROAD Chesterland,  OH  44026
ContactKaren E Warden, Phd
CorrespondentKaren E Warden, Phd
EMBASSY DENTAL LABORATORY 8202 SHERMAN ROAD Chesterland,  OH  44026
Product CodeLRK  
CFR Regulation Number872.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-04-11
Decision Date2011-07-22
Summary:summary

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