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FDA 510(k)

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

K-Number: K160410 · 2016-09-29

ApplicantDental Savings Club
Decision Date2016-09-29
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

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.

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.K241880Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip)Nakanishi, Inc.

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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