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FDA 510(k)

AM-40 POWER OPTIC AIR MOTOR POWER OPTIC CONTRA ANG

K-Number: K850344 · 1985-03-25

ApplicantMidwest
Decision Date1985-03-25
Product CodeEGS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AM-40 POWER OPTIC AIR MOTOR POWER OPTIC CONTRA ANG is the device name listed in this FDA 510(k) record. The listed applicant is Midwest. It received FDA 510(k) clearance on 1985-03-25 under 510(k) number K850344. 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 AM-40 POWER OPTIC AIR MOTOR POWER OPTIC CONTRA ANG?

AM-40 POWER OPTIC AIR MOTOR POWER OPTIC CONTRA ANG is a medical device that received FDA 510(k) clearance on 1985-03-25. The listed applicant is Midwest. The 510(k) number is K850344.

When did AM-40 POWER OPTIC AIR MOTOR POWER OPTIC CONTRA ANG receive FDA 510(k) clearance?

AM-40 POWER OPTIC AIR MOTOR POWER OPTIC CONTRA ANG received FDA 510(k) clearance on 1985-03-25, under 510(k) number K850344.

Who is the listed applicant for AM-40 POWER OPTIC AIR MOTOR POWER OPTIC CONTRA ANG?

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

What is the FDA product code for AM-40 POWER OPTIC AIR MOTOR POWER OPTIC CONTRA ANG?

The FDA product code for AM-40 POWER OPTIC AIR MOTOR POWER OPTIC CONTRA ANG is EGS.

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Other records listing Midwest as applicant

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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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