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FDA 510(k)

Premium Plus Prophy Air Motor

K-Number: K170261 · 2017-10-19

ApplicantPremium Plus International Limited
Decision Date2017-10-19
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Premium Plus Prophy Air Motor is the device name listed in this FDA 510(k) record. The listed applicant is Premium Plus International Limited. It received FDA 510(k) clearance on 2017-10-19 under 510(k) number K170261. 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 Premium Plus Prophy Air Motor?

Premium Plus Prophy Air Motor is a medical device that received FDA 510(k) clearance on 2017-10-19. The listed applicant is Premium Plus International Limited. The 510(k) number is K170261.

When did Premium Plus Prophy Air Motor receive FDA 510(k) clearance?

Premium Plus Prophy Air Motor received FDA 510(k) clearance on 2017-10-19, under 510(k) number K170261.

Who is the listed applicant for Premium Plus Prophy Air Motor?

The FDA 510(k) record lists Premium Plus International Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Premium Plus Prophy Air Motor?

The FDA product code for Premium Plus Prophy Air Motor is EFB.

Other records listing Premium Plus International Limited as applicant

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.

K163447Premium Plus Disposable Barrier SleeveK153514Premium Plus C01/C02 LED Curing Light

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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