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FDA 510(k)

MIDWEST 300 SE

K-Number: K962877 · 1996-10-18

ApplicantMidwest Dental Products Corp.
Decision Date1996-10-18
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MIDWEST 300 SE 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 1996-10-18 under 510(k) number K962877. 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 300 SE?

MIDWEST 300 SE is a medical device that received FDA 510(k) clearance on 1996-10-18. The listed applicant is Midwest Dental Products Corp.. The 510(k) number is K962877.

When did MIDWEST 300 SE receive FDA 510(k) clearance?

MIDWEST 300 SE received FDA 510(k) clearance on 1996-10-18, under 510(k) number K962877.

Who is the listed applicant for MIDWEST 300 SE?

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 300 SE?

The FDA product code for MIDWEST 300 SE 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 SYSTEMK963050TRADITION P, PUSH BUTTON HANDPIECEK955655MIDWEST ONE

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.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.K251389High speed air turbine handpieceFoshan 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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