FDA 510(k)

Absoanchor Microimplant

K-Number: K181142 · 2019-02-05

Decision Date2019-02-05

Product CodeOAT

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Absoanchor Microimplant is the device name listed in this FDA 510(k) record. The listed applicant is Dentos, Inc.. It received FDA 510(k) clearance on 2019-02-05 under 510(k) number K181142. 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 Absoanchor Microimplant?

Absoanchor Microimplant is a medical device that received FDA 510(k) clearance on 2019-02-05. The listed applicant is Dentos, Inc.. The 510(k) number is K181142.

When did Absoanchor Microimplant receive FDA 510(k) clearance?

Absoanchor Microimplant received FDA 510(k) clearance on 2019-02-05, under 510(k) number K181142.

Who is the listed applicant for Absoanchor Microimplant?

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

What is the FDA product code for Absoanchor Microimplant?

The FDA product code for Absoanchor Microimplant is OAT.

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 Sirketi K231913T-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.