FDA 510(k)

3M® Clarity® Aligners (3M® Clarity® Aligners-Force, 3M® Clarity® Aligners-Flex)

Número K: K231464 · 2023-05-22

Requerente3M Company, Unitek Orthodontic Products

Data da decisão2023-05-22

Código do produtoNXC

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

3M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force, 3M™ Clarity™ Aligners-Flex) is the device name listed in this FDA 510(k) record. The listed applicant is 3M Company, Unitek Orthodontic Products. It received FDA 510(k) clearance on 2023-05-22 under 510(k) number K231464. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the 3M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force, 3M™ Clarity™ Aligners-Flex)?

3M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force, 3M™ Clarity™ Aligners-Flex) is a medical device that received FDA 510(k) clearance on 2023-05-22. The listed applicant is 3M Company, Unitek Orthodontic Products. The 510(k) number is K231464.

When did 3M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force, 3M™ Clarity™ Aligners-Flex) receive FDA 510(k) clearance?

3M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force, 3M™ Clarity™ Aligners-Flex) received FDA 510(k) clearance on 2023-05-22, under 510(k) number K231464.

Who is the listed applicant for 3M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force, 3M™ Clarity™ Aligners-Flex)?

The FDA 510(k) record lists 3M Company, Unitek Orthodontic Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force, 3M™ Clarity™ Aligners-Flex)?

The FDA product code for 3M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force, 3M™ Clarity™ Aligners-Flex) is NXC.

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Outros registros que listam 3M Company, Unitek Orthodontic Products como candidato(a)

K2332573M® Clarity®Aligners with Quick Attachments K2111903M Clarity Alinhadores (3M Clarity Alinhadores-Force, 3M Clarity Alinhadores-Flex)

Dispositivos Relacionados (Código: NXC)

K260527FACE4D AlignerAvinent Implant System S.L.U.K260788Smylio AlignersSmylio, Inc.K260722SureSmile Aligner (ASSY500020)Dentsply Sirona, Inc.K253282ZSmile SystemDror Orthodesign , Ltd.K251454Clear Aligner (SCF-3348)Beame Medical Technology (Shenzhen) Limited K250739Primeprint Direct AlignerDreve Dentamid GmbH

Fonte oficial

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