FULL BREATH SLEEP APPLIANCE - AB (ANTERIOR BITE)

Device, Jaw Repositioning

BRYAN KEROPIAN DDS

The following data is part of a premarket notification filed by Bryan Keropian Dds with the FDA for Full Breath Sleep Appliance - Ab (anterior Bite).

Pre-market Notification Details

Device IDK052862
510k NumberK052862
Device Name:FULL BREATH SLEEP APPLIANCE - AB (ANTERIOR BITE)
ClassificationDevice, Jaw Repositioning
Applicant BRYAN KEROPIAN DDS 18607 VENTURA BLVD., SUITE 206 Tarzana,  CA  91356
ContactBryan Keropian
CorrespondentBryan Keropian
BRYAN KEROPIAN DDS 18607 VENTURA BLVD., SUITE 206 Tarzana,  CA  91356
Product CodeLQZ  
CFR Regulation Number872.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-10-11
Decision Date2005-12-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
D85463252S1 K052862 000
D85463251S1 K052862 000
D85463250TS1 K052862 000
D85463250SLS1 K052862 000
D85463250S1 K052862 000
D85463250PS1 K052862 000
D85463250AS1 K052862 000
D85463250AHS1 K052862 000

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