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FDA 510(k)

MIDWEST ONE

K-Number: K955655 · 1996-03-05

ApplicantMidwest Dental Products Corp.
Decision Date1996-03-05
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MIDWEST ONE is the device name listed in this FDA 510(k) record. The listed applicant is Midwest Dental Products Corp.. It received FDA 510(k) clearance on 1996-03-05 under 510(k) number K955655. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MIDWEST ONE?

MIDWEST ONE is a medical device that received FDA 510(k) clearance on 1996-03-05. The listed applicant is Midwest Dental Products Corp.. The 510(k) number is K955655.

When did MIDWEST ONE receive FDA 510(k) clearance?

MIDWEST ONE received FDA 510(k) clearance on 1996-03-05, under 510(k) number K955655.

Who is the listed applicant for MIDWEST ONE?

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

What is the FDA product code for MIDWEST ONE?

The FDA product code for MIDWEST ONE is EFB.

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 Midwest Dental Products Corp. 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.

K97380023:1 REDUCTION ANGLEK964755MICROJET CAVITY PREPARATION SYSTEMK962877MIDWEST 300 SEK963050TRADITION P, PUSH BUTTON HANDPIECE

Related Devices (Code: EFB)

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.

K262144DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor HandpieceSETAGAYA SEIKI Co., Ltd.K251389High speed air turbine handpieceFoshan Topmed Dental Co., Ltd.K251388Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41)Foshan Topmed Dental Co., Ltd.K242179Synea Fusion Handpieces (Intensiv & Profin)W&H Dentalwerk Bürmoos GmbHK240337Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)Guangdong Jinme Medical Technology Co., Ltd.K241074High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M)Foshan Soco Precision Instrument 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.

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