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FDA 510(k)

TRADITION HIGH SPEED HANDPIECE

K-Number: K863677 · 1986-10-06

ApplicantMidwest
Decision Date1986-10-06
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TRADITION HIGH SPEED HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Midwest. It received FDA 510(k) clearance on 1986-10-06 under 510(k) number K863677. 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 TRADITION HIGH SPEED HANDPIECE?

TRADITION HIGH SPEED HANDPIECE is a medical device that received FDA 510(k) clearance on 1986-10-06. The listed applicant is Midwest. The 510(k) number is K863677.

When did TRADITION HIGH SPEED HANDPIECE receive FDA 510(k) clearance?

TRADITION HIGH SPEED HANDPIECE received FDA 510(k) clearance on 1986-10-06, under 510(k) number K863677.

Who is the listed applicant for TRADITION HIGH SPEED HANDPIECE?

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 TRADITION HIGH SPEED HANDPIECE?

The FDA product code for TRADITION HIGH SPEED HANDPIECE is EFB.

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Other records listing Midwest 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.

K850344AM-40 POWER OPTIC AIR MOTOR POWER OPTIC CONTRA ANGK792445MW STRAIGHT ATTACHMENTK792304MW-8000K792302LS-100K792303MW 8000-IK791771ORALUMINATOR III AUTO-LIGHT

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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

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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