FDA 510(k)

Dental Air Polishing Handpiece

N.º K: K221548 · 2022-09-28

SolicitanteGuilin Woodpecker Medical Instrument Co., Ltd.

Fecha de decisión2022-09-28

Código de productoEFB

Comité asesorDE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Dental Air Polishing Handpiece is the device name listed in this FDA 510(k) record. The listed applicant is Guilin Woodpecker Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2022-09-28 under 510(k) number K221548. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Dental Air Polishing Handpiece?

Dental Air Polishing Handpiece is a medical device that received FDA 510(k) clearance on 2022-09-28. The listed applicant is Guilin Woodpecker Medical Instrument Co., Ltd.. The 510(k) number is K221548.

When did Dental Air Polishing Handpiece receive FDA 510(k) clearance?

Dental Air Polishing Handpiece received FDA 510(k) clearance on 2022-09-28, under 510(k) number K221548.

Who is the listed applicant for Dental Air Polishing Handpiece?

The FDA 510(k) record lists Guilin Woodpecker Medical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dental Air Polishing Handpiece?

The FDA product code for Dental Air Polishing Handpiece is EFB.

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Otros registros que enlistan a Guilin Woodpecker Medical Instrument Co., Ltd. como solicitante

K251438Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )K222569Dispositivo de Rayos X Dental Ai Ray K211358Implanter incl. Accessories K210367D-Laser Blue, D-Laser 16 K203706Dental Electric Motor K211531Cordless Prophy System, Model: i-Polish

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Dispositivos relacionados (Código: 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.

Fuente oficial

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