ORTHODONTIC SCREW

Implant, Endosseous, Orthodontic

OSSTEM IMPLANT CO.,LTD

The following data is part of a premarket notification filed by Osstem Implant Co.,ltd with the FDA for Orthodontic Screw.

Pre-market Notification Details

Device IDK103105
510k NumberK103105
Device Name:ORTHODONTIC SCREW
ClassificationImplant, Endosseous, Orthodontic
Applicant OSSTEM IMPLANT CO.,LTD 85 BEN FAIRLESS DR. Fairless Hills,  PA  19030
ContactPatrick Lim
CorrespondentPatrick Lim
OSSTEM IMPLANT CO.,LTD 85 BEN FAIRLESS DR. Fairless Hills,  PA  19030
Product CodeOAT  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-10-20
Decision Date2011-03-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08809917110497 K103105 000
08809917109576 K103105 000
08809917109620 K103105 000
08809917109668 K103105 000
08809917109705 K103105 000
08809917109750 K103105 000
08809917109798 K103105 000
08809917109835 K103105 000
08809917110114 K103105 000
08809917110169 K103105 000
08809917110244 K103105 000
08809917110329 K103105 000
08809917110374 K103105 000
08809917110411 K103105 000
08809917110459 K103105 000
08809917109552 K103105 000

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