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FDA 510(k)

STORM MINI SCREW

K-Number: K122069 · 2013-04-11

ApplicantLancer Orthodontics, Inc.
Decision Date2013-04-11
Product CodeOAT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

STORM MINI SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Lancer Orthodontics, Inc.. It received FDA 510(k) clearance on 2013-04-11 under 510(k) number K122069. 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 STORM MINI SCREW?

STORM MINI SCREW is a medical device that received FDA 510(k) clearance on 2013-04-11. The listed applicant is Lancer Orthodontics, Inc.. The 510(k) number is K122069.

When did STORM MINI SCREW receive FDA 510(k) clearance?

STORM MINI SCREW received FDA 510(k) clearance on 2013-04-11, under 510(k) number K122069.

Who is the listed applicant for STORM MINI SCREW?

The FDA 510(k) record lists Lancer Orthodontics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STORM MINI SCREW?

The FDA product code for STORM MINI SCREW is OAT.

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Other records listing Lancer Orthodontics, Inc. 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.

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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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