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FDA 510(k)

PACEMAKER HIGH-SPEED HANDPIECE MODEL PM-MQ, PM-M

K-Number: K101551 · 2010-09-09

ApplicantDelma Medical Instrument (Guangzhou) Co., Ltd.
Decision Date2010-09-09
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PACEMAKER HIGH-SPEED HANDPIECE MODEL PM-MQ, PM-M is the device name listed in this FDA 510(k) record. The listed applicant is Delma Medical Instrument (Guangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2010-09-09 under 510(k) number K101551. 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 PACEMAKER HIGH-SPEED HANDPIECE MODEL PM-MQ, PM-M?

PACEMAKER HIGH-SPEED HANDPIECE MODEL PM-MQ, PM-M is a medical device that received FDA 510(k) clearance on 2010-09-09. The listed applicant is Delma Medical Instrument (Guangzhou) Co., Ltd.. The 510(k) number is K101551.

When did PACEMAKER HIGH-SPEED HANDPIECE MODEL PM-MQ, PM-M receive FDA 510(k) clearance?

PACEMAKER HIGH-SPEED HANDPIECE MODEL PM-MQ, PM-M received FDA 510(k) clearance on 2010-09-09, under 510(k) number K101551.

Who is the listed applicant for PACEMAKER HIGH-SPEED HANDPIECE MODEL PM-MQ, PM-M?

The FDA 510(k) record lists Delma Medical Instrument (Guangzhou) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PACEMAKER HIGH-SPEED HANDPIECE MODEL PM-MQ, PM-M?

The FDA product code for PACEMAKER HIGH-SPEED HANDPIECE MODEL PM-MQ, PM-M 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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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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