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FDA 510(k)

MAXIMA-M STRAIGHT ATTACHMENT, MAXIMA-M CONTRA ANGLE SHEATH

K-Number: K092053 · 2009-08-20

ApplicantHandpiece Headquarters
Decision Date2009-08-20
Product CodeEGS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MAXIMA-M STRAIGHT ATTACHMENT, MAXIMA-M CONTRA ANGLE SHEATH is the device name listed in this FDA 510(k) record. The listed applicant is Handpiece Headquarters. It received FDA 510(k) clearance on 2009-08-20 under 510(k) number K092053. 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 MAXIMA-M STRAIGHT ATTACHMENT, MAXIMA-M CONTRA ANGLE SHEATH?

MAXIMA-M STRAIGHT ATTACHMENT, MAXIMA-M CONTRA ANGLE SHEATH is a medical device that received FDA 510(k) clearance on 2009-08-20. The listed applicant is Handpiece Headquarters. The 510(k) number is K092053.

When did MAXIMA-M STRAIGHT ATTACHMENT, MAXIMA-M CONTRA ANGLE SHEATH receive FDA 510(k) clearance?

MAXIMA-M STRAIGHT ATTACHMENT, MAXIMA-M CONTRA ANGLE SHEATH received FDA 510(k) clearance on 2009-08-20, under 510(k) number K092053.

Who is the listed applicant for MAXIMA-M STRAIGHT ATTACHMENT, MAXIMA-M CONTRA ANGLE SHEATH?

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

What is the FDA product code for MAXIMA-M STRAIGHT ATTACHMENT, MAXIMA-M CONTRA ANGLE SHEATH?

The FDA product code for MAXIMA-M STRAIGHT ATTACHMENT, MAXIMA-M CONTRA ANGLE SHEATH is EGS.

Related Clinical Trials

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Other records listing Handpiece Headquarters 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.

K243911HPR Cordless Hygiene HandpieceK233518BASE290 LED Curing LightK100389HHC PUSH-BUTTON REPLACEMENT TURBINE FOR MIDWEST TRADITION HANDPIECE MODEL MW TURBINE REPLACEMENT

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

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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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