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FDA 510(k)

INFINITAS MINI-IMPLANT MODEL: DB10-0009, DB10-0010,DB10-0012,DB10-0015,DB10-0016

K-Number: K100633 · 2010-04-01

ApplicantD B Orthodontics, Ltd.
Decision Date2010-04-01
Product CodeOAT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

INFINITAS MINI-IMPLANT MODEL: DB10-0009, DB10-0010,DB10-0012,DB10-0015,DB10-0016 is the device name listed in this FDA 510(k) record. The listed applicant is D B Orthodontics, Ltd.. It received FDA 510(k) clearance on 2010-04-01 under 510(k) number K100633. 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 INFINITAS MINI-IMPLANT MODEL: DB10-0009, DB10-0010,DB10-0012,DB10-0015,DB10-0016?

INFINITAS MINI-IMPLANT MODEL: DB10-0009, DB10-0010,DB10-0012,DB10-0015,DB10-0016 is a medical device that received FDA 510(k) clearance on 2010-04-01. The listed applicant is D B Orthodontics, Ltd.. The 510(k) number is K100633.

When did INFINITAS MINI-IMPLANT MODEL: DB10-0009, DB10-0010,DB10-0012,DB10-0015,DB10-0016 receive FDA 510(k) clearance?

INFINITAS MINI-IMPLANT MODEL: DB10-0009, DB10-0010,DB10-0012,DB10-0015,DB10-0016 received FDA 510(k) clearance on 2010-04-01, under 510(k) number K100633.

Who is the listed applicant for INFINITAS MINI-IMPLANT MODEL: DB10-0009, DB10-0010,DB10-0012,DB10-0015,DB10-0016?

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

What is the FDA product code for INFINITAS MINI-IMPLANT MODEL: DB10-0009, DB10-0010,DB10-0012,DB10-0015,DB10-0016?

The FDA product code for INFINITAS MINI-IMPLANT MODEL: DB10-0009, DB10-0010,DB10-0012,DB10-0015,DB10-0016 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 D B Orthodontics, 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.

K072086INFINITAS MINI-IMPLANT SYSTEM/GUIDANCE 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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