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FDA 510(k)

CROMAX HIGH SPEED TURBINE HANDPIECE

K-Number: K041755 · 2004-10-22

ApplicantJ.R. Medical Technologies, Inc.
Decision Date2004-10-22
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CROMAX HIGH SPEED TURBINE HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is J.R. Medical Technologies, Inc.. It received FDA 510(k) clearance on 2004-10-22 under 510(k) number K041755. 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 CROMAX HIGH SPEED TURBINE HANDPIECE?

CROMAX HIGH SPEED TURBINE HANDPIECE is a medical device that received FDA 510(k) clearance on 2004-10-22. The listed applicant is J.R. Medical Technologies, Inc.. The 510(k) number is K041755.

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

CROMAX HIGH SPEED TURBINE HANDPIECE received FDA 510(k) clearance on 2004-10-22, under 510(k) number K041755.

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

The FDA 510(k) record lists J.R. Medical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for CROMAX HIGH SPEED TURBINE HANDPIECE is EFB.

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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

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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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