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FDA 510(k)

Mico One Orthodontic Screw

K-Number: K202163 · 2022-10-07

ApplicantZe Fang Technology Co., Ltd.
Decision Date2022-10-07
Product CodeOAT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Mico One Orthodontic Screw is a medical device manufactured by Ze Fang Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-10-07 under approval number K202163. The device is classified under product code OAT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Mico One Orthodontic Screw?

Mico One Orthodontic Screw is a medical device that received FDA 510(k) clearance on 2022-10-07. It is manufactured by Ze Fang Technology Co., Ltd.. The 510(k) number is K202163.

When was Mico One Orthodontic Screw approved by the FDA?

Mico One Orthodontic Screw received FDA 510(k) clearance on 2022-10-07, under approval number K202163.

What company makes Mico One Orthodontic Screw?

Mico One Orthodontic Screw is manufactured by Ze Fang Technology Co., Ltd..

What is the FDA product code for Mico One Orthodontic Screw?

The FDA product code for Mico One Orthodontic Screw is OAT.

Related Clinical Trials

NCT07362160 Clear Orthodontic Expander Versus Hyrax RECRUITING

Related Devices (Code: OAT)

K161197Orthodontic ScrewOsstem Implant Co., Ltd. K152297OBS Anchorage ScrewBomei Co, Ltd. K161335Dual Top Screw SystemJeil Medical Corporation K173623Anchor plateBiomaterials Korea, Inc. K182929BIO-RAY A-1 Anchor Screw SystemMicroware Precision Co., Ltd. K181142Absoanchor MicroimplantDentos, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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