FACEBOW

Headgear, Extraoral, Orthodontic

ORTHO KINETICS CORP.

The following data is part of a premarket notification filed by Ortho Kinetics Corp. with the FDA for Facebow.

Pre-market Notification Details

Device IDK980195
510k NumberK980195
Device Name:FACEBOW
ClassificationHeadgear, Extraoral, Orthodontic
Applicant ORTHO KINETICS CORP. 1611A SOUTH MELROSE DR. SUITE 16 Vista,  CA  92083 -5407
ContactSteven O Luse
CorrespondentSteven O Luse
ORTHO KINETICS CORP. 1611A SOUTH MELROSE DR. SUITE 16 Vista,  CA  92083 -5407
Product CodeDZB  
CFR Regulation Number872.5500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-01-20
Decision Date1998-03-11

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00190707000554 K980195 000

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