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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 the device name listed in this FDA 510(k) record. The listed applicant is Ze Fang Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-10-07 under 510(k) 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. The listed applicant is Ze Fang Technology Co., Ltd.. The 510(k) number is K202163.

When did Mico One Orthodontic Screw receive FDA 510(k) clearance?

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

Who is the listed applicant for Mico One Orthodontic Screw?

The FDA 510(k) record lists Ze Fang Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: OAT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260268OrthoEasy Pal; OrthoEasy Pal Long NeckBernhard Förster GmbH (Bernhard Foerster Ltd.)K242944Leone Orthodontic Implant TAD (Temporary Anchorage Device)Leone S.P.A.K231502Mini ScrewsProimtech Saglik Urunleri Anonim SirketiK231913T-FITTechwin Co., Ltd.K222245ACR Screw SystemBiomaterials Korea, Inc.K202691Ortholock Anchorage DevicesCraniofacial Technologies, 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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