FDA 510(k)

EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE

K-Number: K022119 · 2002-07-25

Decision Date2002-07-25

Product CodeEFB

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Electro Medical Systems SA. It received FDA 510(k) clearance on 2002-07-25 under 510(k) number K022119. 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 EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE?

EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE is a medical device that received FDA 510(k) clearance on 2002-07-25. The listed applicant is Electro Medical Systems SA. The 510(k) number is K022119.

When did EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE receive FDA 510(k) clearance?

EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE received FDA 510(k) clearance on 2002-07-25, under 510(k) number K022119.

Who is the listed applicant for EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE?

The FDA 510(k) record lists Electro Medical Systems SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE?

The FDA product code for EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE is EFB.

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Other records listing Electro Medical Systems SA as applicant

K022328EMS PIEZON MASTER 600 K012445EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA)K002484EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL K992251SWISS LITHOCLAST MULTIPURPOSE PROBE K963285EMS SWISS LITHOCLAST LITHOTRIPTER K964111LITHOVAC SUCTION/ASPIRATION PROBE

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Related Devices (Code: EFB)

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 GmbH K240337Dental 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.