Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ORTHODONTIC TEMPORARY ANCHORAGE IMPLANT SCREW

K-Number: K081393 · 2008-08-21

ApplicantG & H Wire Co.
Decision Date2008-08-21
Product CodeOAT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORTHODONTIC TEMPORARY ANCHORAGE IMPLANT SCREW is the device name listed in this FDA 510(k) record. The listed applicant is G & H Wire Co.. It received FDA 510(k) clearance on 2008-08-21 under 510(k) number K081393. 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 TEMPORARY ANCHORAGE IMPLANT SCREW?

ORTHODONTIC TEMPORARY ANCHORAGE IMPLANT SCREW is a medical device that received FDA 510(k) clearance on 2008-08-21. The listed applicant is G & H Wire Co.. The 510(k) number is K081393.

When did ORTHODONTIC TEMPORARY ANCHORAGE IMPLANT SCREW receive FDA 510(k) clearance?

ORTHODONTIC TEMPORARY ANCHORAGE IMPLANT SCREW received FDA 510(k) clearance on 2008-08-21, under 510(k) number K081393.

Who is the listed applicant for ORTHODONTIC TEMPORARY ANCHORAGE IMPLANT SCREW?

The FDA 510(k) record lists G & H Wire Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORTHODONTIC TEMPORARY ANCHORAGE IMPLANT SCREW?

The FDA product code for ORTHODONTIC TEMPORARY ANCHORAGE IMPLANT SCREW is OAT.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing G & H Wire Co. 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.

K961754SAFETY RELEASE MODULE

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.

↑