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FDA 510(k)

QAR HANDPIECE

K-Number: K904671 · 1990-12-21

ApplicantCollagen Corp.
Decision Date1990-12-21
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

QAR HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Collagen Corp.. It received FDA 510(k) clearance on 1990-12-21 under 510(k) number K904671. 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 QAR HANDPIECE?

QAR HANDPIECE is a medical device that received FDA 510(k) clearance on 1990-12-21. The listed applicant is Collagen Corp.. The 510(k) number is K904671.

When did QAR HANDPIECE receive FDA 510(k) clearance?

QAR HANDPIECE received FDA 510(k) clearance on 1990-12-21, under 510(k) number K904671.

Who is the listed applicant for QAR HANDPIECE?

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

What is the FDA product code for QAR HANDPIECE?

The FDA product code for QAR HANDPIECE is EFB.

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Other records listing Collagen 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.

K904228OSSEODENT DENTAL ATTACHMENTS (NON-ANGLED)K901600OSSEOTITE IRRIGATION UNITK900275OSSEODENT DENTAL ATTACHMENT, IGLOO MAGNETK895462OSSEODENT DENTAL ATTACHMENTSK895463OSSEODENT(R) PRECISION DENTAL ATTACHMENTSK894331OSSEODENT SURGICAL KIT

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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.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

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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