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FDA 510(k)

ALPHA-BIO ORTHODONTIC FIXATION SCREW SYSTEM

K-Number: K063770 · 2007-03-26

ApplicantAlpha-Bio Tec , Ltd.
Decision Date2007-03-26
Product CodeOAT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ALPHA-BIO ORTHODONTIC FIXATION SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Alpha-Bio Tec , Ltd.. It received FDA 510(k) clearance on 2007-03-26 under 510(k) number K063770. 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 ALPHA-BIO ORTHODONTIC FIXATION SCREW SYSTEM?

ALPHA-BIO ORTHODONTIC FIXATION SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2007-03-26. The listed applicant is Alpha-Bio Tec , Ltd.. The 510(k) number is K063770.

When did ALPHA-BIO ORTHODONTIC FIXATION SCREW SYSTEM receive FDA 510(k) clearance?

ALPHA-BIO ORTHODONTIC FIXATION SCREW SYSTEM received FDA 510(k) clearance on 2007-03-26, under 510(k) number K063770.

Who is the listed applicant for ALPHA-BIO ORTHODONTIC FIXATION SCREW SYSTEM?

The FDA 510(k) record lists Alpha-Bio Tec , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALPHA-BIO ORTHODONTIC FIXATION SCREW SYSTEM?

The FDA product code for ALPHA-BIO ORTHODONTIC FIXATION SCREW SYSTEM 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.

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Other records listing Alpha-Bio Tec , Ltd. 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.

K063769ALPHA BIO BONE FIXATION SCREW SYSTEMK063364ALPHA BIO DENTAL IMPLANT SYSTEM

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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