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FDA 510(k)

EXCEL CONTRA ANGLE HANDPIECE

K-Number: K061897 · 2007-02-14

ApplicantOrthosource, Inc.
Decision Date2007-02-14
Product CodeEGS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EXCEL CONTRA ANGLE HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Orthosource, Inc.. It received FDA 510(k) clearance on 2007-02-14 under 510(k) number K061897. The device is classified under product code EGS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXCEL CONTRA ANGLE HANDPIECE?

EXCEL CONTRA ANGLE HANDPIECE is a medical device that received FDA 510(k) clearance on 2007-02-14. The listed applicant is Orthosource, Inc.. The 510(k) number is K061897.

When did EXCEL CONTRA ANGLE HANDPIECE receive FDA 510(k) clearance?

EXCEL CONTRA ANGLE HANDPIECE received FDA 510(k) clearance on 2007-02-14, under 510(k) number K061897.

Who is the listed applicant for EXCEL CONTRA ANGLE HANDPIECE?

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

What is the FDA product code for EXCEL CONTRA ANGLE HANDPIECE?

The FDA product code for EXCEL CONTRA ANGLE HANDPIECE is EGS.

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 Orthosource, 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.

K061581EXCEL HIGH SPEED DENTAL HANDPIECE

Related Devices (Code: EGS)

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.

K251869Disposable Prophy Angle (3399-60, 3399-090, 3399-105)Premium Plus (Dongguan) LimitedK240950Disposable Prophy AnglePacific Care LimitedK240183Star E900 Handpiece SeriesDentalez, Inc., Stardental DivisionK230106General Cutting StraightNakanishi, Inc.K222518FX ContraNakanishi, Inc.K220874Smooth Drive contra angle and straight handpiecesLares Research

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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