FDA 510(k)

430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES

K-Number: K130455 · 2013-09-25

ApplicantDentalez Group, Stardental Division

Decision Date2013-09-25

Product CodeEFB

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES is the device name listed in this FDA 510(k) record. The listed applicant is Dentalez Group, Stardental Division. It received FDA 510(k) clearance on 2013-09-25 under 510(k) number K130455. 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 430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES?

430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES is a medical device that received FDA 510(k) clearance on 2013-09-25. The listed applicant is Dentalez Group, Stardental Division. The 510(k) number is K130455.

When did 430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES receive FDA 510(k) clearance?

430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES received FDA 510(k) clearance on 2013-09-25, under 510(k) number K130455.

Who is the listed applicant for 430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES?

The FDA 510(k) record lists Dentalez Group, Stardental Division as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES?

The FDA product code for 430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES is EFB.

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Other records listing Dentalez Group, Stardental Division as applicant

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.