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FDA 510(k)

Orthodontic Screw

K-Number: K161197 · 2016-12-21

ApplicantOsstem Implant Co., Ltd.
Decision Date2016-12-21
Product CodeOAT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Orthodontic Screw is the device name listed in this FDA 510(k) record. The listed applicant is Osstem Implant Co., Ltd.. It received FDA 510(k) clearance on 2016-12-21 under 510(k) number K161197. 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 Orthodontic Screw?

Orthodontic Screw is a medical device that received FDA 510(k) clearance on 2016-12-21. The listed applicant is Osstem Implant Co., Ltd.. The 510(k) number is K161197.

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

Orthodontic Screw received FDA 510(k) clearance on 2016-12-21, under 510(k) number K161197.

Who is the listed applicant for Orthodontic Screw?

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

What is the FDA product code for Orthodontic Screw?

The FDA product code for Orthodontic Screw is OAT.

Other records listing Osstem Implant Co., Ltd. as applicant

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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.K202163Mico One Orthodontic ScrewZe Fang Technology Co., Ltd.

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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