Dental Handpiece, Model CA160, CA160L, And CA500L

Handpiece, Belt And/or Gear Driven, Dental

Micro-NX Co., Ltd.

The following data is part of a premarket notification filed by Micro-nx Co., Ltd. with the FDA for Dental Handpiece, Model Ca160, Ca160l, And Ca500l.

Pre-market Notification Details

Device IDK220577
510k NumberK220577
Device Name:Dental Handpiece, Model CA160, CA160L, And CA500L
ClassificationHandpiece, Belt And/or Gear Driven, Dental
Applicant Micro-NX Co., Ltd. 22 Maeyeo-ro 1 Gil Dong-gu,  KR 41059
ContactSojeong Park
CorrespondentSeohee Kwon
K-Bio Solutions 201 South 4th Street, Suite 727 San Jose,  CA  95112
Product CodeEFA  
CFR Regulation Number872.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-02-28
Decision Date2022-07-29

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