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FDA 510(k)

CST61 HIGH SPEED TURBINE HANDPIECE

K-Number: K063110 · 2006-10-26

ApplicantShanghai Dental Instrument Factory
Decision Date2006-10-26
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CST61 HIGH SPEED TURBINE HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Dental Instrument Factory. It received FDA 510(k) clearance on 2006-10-26 under 510(k) number K063110. 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 CST61 HIGH SPEED TURBINE HANDPIECE?

CST61 HIGH SPEED TURBINE HANDPIECE is a medical device that received FDA 510(k) clearance on 2006-10-26. The listed applicant is Shanghai Dental Instrument Factory. The 510(k) number is K063110.

When did CST61 HIGH SPEED TURBINE HANDPIECE receive FDA 510(k) clearance?

CST61 HIGH SPEED TURBINE HANDPIECE received FDA 510(k) clearance on 2006-10-26, under 510(k) number K063110.

Who is the listed applicant for CST61 HIGH SPEED TURBINE HANDPIECE?

The FDA 510(k) record lists Shanghai Dental Instrument Factory as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CST61 HIGH SPEED TURBINE HANDPIECE?

The FDA product code for CST61 HIGH SPEED TURBINE HANDPIECE 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 Shanghai Dental Instrument Factory 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.

K063302SDIF DENTAL CHAIR WITH OPERATIVE UNIT AND ACCESSORIES

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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