FDA 510(k)

WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head

Numéro K : K160410 · 2016-09-29

Date de décision2016-09-29

Code produitEFB

Comité consultatifDE

DécisionSubstantially Equivalent

Résumé du dispositif

WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head is the device name listed in this FDA 510(k) record. The listed applicant is Dental Savings Club. It received FDA 510(k) clearance on 2016-09-29 under 510(k) number K160410. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head?

WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head is a medical device that received FDA 510(k) clearance on 2016-09-29. The listed applicant is Dental Savings Club. The 510(k) number is K160410.

When did WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head receive FDA 510(k) clearance?

WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head received FDA 510(k) clearance on 2016-09-29, under 510(k) number K160410.

Who is the listed applicant for WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head?

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

What is the FDA product code for WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head?

The FDA product code for WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head is EFB.

Essais cliniques associés

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Dispositifs connexes (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.

Source officielle

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