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FDA 510(k)

DAWN LOW SPEED HANDPIECE SYSTEM

K-Number: K821484 · 1982-06-09

ApplicantYoung Dental Manufacturing Co. 1, LLC
Decision Date1982-06-09
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DAWN LOW SPEED HANDPIECE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Young Dental Manufacturing Co. 1, LLC. It received FDA 510(k) clearance on 1982-06-09 under 510(k) number K821484. 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 DAWN LOW SPEED HANDPIECE SYSTEM?

DAWN LOW SPEED HANDPIECE SYSTEM is a medical device that received FDA 510(k) clearance on 1982-06-09. The listed applicant is Young Dental Manufacturing Co. 1, LLC. The 510(k) number is K821484.

When did DAWN LOW SPEED HANDPIECE SYSTEM receive FDA 510(k) clearance?

DAWN LOW SPEED HANDPIECE SYSTEM received FDA 510(k) clearance on 1982-06-09, under 510(k) number K821484.

Who is the listed applicant for DAWN LOW SPEED HANDPIECE SYSTEM?

The FDA 510(k) record lists Young Dental Manufacturing Co. 1, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DAWN LOW SPEED HANDPIECE SYSTEM?

The FDA product code for DAWN LOW SPEED HANDPIECE SYSTEM is EFB.

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Other records listing Young Dental Manufacturing Co. 1, LLC 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.

K241041Silver Fluoride Hypersensitivity VarnishK201127DEFEND Ear-loop Face MasksK171377Young INFINITY Cordless Handpiece SystemK153334Oral-B 5% Sodium Fluoride VarnishK932255YOUNG D'GRANULATORK903284YOUNG PROPHY SYSTEM, PS UNIT

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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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