FDA 510(k)

3M® Transbond® Orthodontic Adhesive

Número K: K234043 · 2023-12-22

Requerente3M Unitek Orthodontic Products

Data da decisão2023-12-22

Código do produtoDYH

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

3M™ Transbond™ Orthodontic Adhesive is the device name listed in this FDA 510(k) record. The listed applicant is 3M Unitek Orthodontic Products. It received FDA 510(k) clearance on 2023-12-22 under 510(k) number K234043. The device is classified under product code DYH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the 3M™ Transbond™ Orthodontic Adhesive?

3M™ Transbond™ Orthodontic Adhesive is a medical device that received FDA 510(k) clearance on 2023-12-22. The listed applicant is 3M Unitek Orthodontic Products. The 510(k) number is K234043.

When did 3M™ Transbond™ Orthodontic Adhesive receive FDA 510(k) clearance?

3M™ Transbond™ Orthodontic Adhesive received FDA 510(k) clearance on 2023-12-22, under 510(k) number K234043.

Who is the listed applicant for 3M™ Transbond™ Orthodontic Adhesive?

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

What is the FDA product code for 3M™ Transbond™ Orthodontic Adhesive?

The FDA product code for 3M™ Transbond™ Orthodontic Adhesive is DYH.

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