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FDA 510(k)

NEODENT IMPLANT FOR ORTHODONTIC ANCHORAGE

K-Number: K102769 · 2011-02-23

ApplicantJjgc Industria E Comercio DE Materiais Dentarios S
Decision Date2011-02-23
Product CodeOAT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NEODENT IMPLANT FOR ORTHODONTIC ANCHORAGE is the device name listed in this FDA 510(k) record. The listed applicant is Jjgc Industria E Comercio DE Materiais Dentarios S. It received FDA 510(k) clearance on 2011-02-23 under 510(k) number K102769. 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 NEODENT IMPLANT FOR ORTHODONTIC ANCHORAGE?

NEODENT IMPLANT FOR ORTHODONTIC ANCHORAGE is a medical device that received FDA 510(k) clearance on 2011-02-23. The listed applicant is Jjgc Industria E Comercio DE Materiais Dentarios S. The 510(k) number is K102769.

When did NEODENT IMPLANT FOR ORTHODONTIC ANCHORAGE receive FDA 510(k) clearance?

NEODENT IMPLANT FOR ORTHODONTIC ANCHORAGE received FDA 510(k) clearance on 2011-02-23, under 510(k) number K102769.

Who is the listed applicant for NEODENT IMPLANT FOR ORTHODONTIC ANCHORAGE?

The FDA 510(k) record lists Jjgc Industria E Comercio DE Materiais Dentarios S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEODENT IMPLANT FOR ORTHODONTIC ANCHORAGE?

The FDA product code for NEODENT IMPLANT FOR ORTHODONTIC ANCHORAGE 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 Jjgc Industria E Comercio DE Materiais Dentarios S 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.

K153624Neodent Implant SystemK123022NEODENT IMPLANT SYSTEMK103084NEODENT GRAFT SCREWK101945NEODENT IMPLANT SYSTEMK101207NEODENT 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

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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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