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FDA 510(k)

SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS

K-Number: K111809 · 2011-09-26

ApplicantBiomaterials Korea, Inc.
Decision Date2011-09-26
Product CodeOAT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS is the device name listed in this FDA 510(k) record. The listed applicant is Biomaterials Korea, Inc.. It received FDA 510(k) clearance on 2011-09-26 under 510(k) number K111809. 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 SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS?

SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS is a medical device that received FDA 510(k) clearance on 2011-09-26. The listed applicant is Biomaterials Korea, Inc.. The 510(k) number is K111809.

When did SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS receive FDA 510(k) clearance?

SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS received FDA 510(k) clearance on 2011-09-26, under 510(k) number K111809.

Who is the listed applicant for SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS?

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

What is the FDA product code for SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS?

The FDA product code for SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS is OAT.

Related Clinical Trials

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Other records listing Biomaterials Korea, 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.

K222245ACR Screw SystemK173623Anchor plateK110926BONE PLATE; BONE SCREWK063495C TYPE, CT TYPE, AND SPECIAL TYPE ORTHODONTIC ANCHOR SCREWS

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

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