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FDA 510(k)

Mini Screws

K-Number: K231502 · 2024-09-04

ApplicantProimtech Saglik Urunleri Anonim Sirketi
Decision Date2024-09-04
Product CodeOAT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Mini Screws is the device name listed in this FDA 510(k) record. The listed applicant is Proimtech Saglik Urunleri Anonim Sirketi. It received FDA 510(k) clearance on 2024-09-04 under 510(k) number K231502. 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 Mini Screws?

Mini Screws is a medical device that received FDA 510(k) clearance on 2024-09-04. The listed applicant is Proimtech Saglik Urunleri Anonim Sirketi. The 510(k) number is K231502.

When did Mini Screws receive FDA 510(k) clearance?

Mini Screws received FDA 510(k) clearance on 2024-09-04, under 510(k) number K231502.

Who is the listed applicant for Mini Screws?

The FDA 510(k) record lists Proimtech Saglik Urunleri Anonim Sirketi as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mini Screws?

The FDA product code for Mini Screws is OAT.

Other records listing Proimtech Saglik Urunleri Anonim Sirketi as applicant

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.

K233419GBR SystemK231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech Abutment Screw

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.K231913T-FITTechwin Co., Ltd.K222245ACR Screw SystemBiomaterials Korea, Inc.K202163Mico One Orthodontic ScrewZe Fang Technology Co., Ltd.K202691Ortholock Anchorage DevicesCraniofacial Technologies, Inc.

Official Source

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

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