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FDA 510(k)

3M™ Transbond™ Orthodontic Adhesive

K-Number: K234043 · 2023-12-22

Decision Date2023-12-22
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by 3M Unitek Orthodontic Products. The 510(k) number is K234043.

When was 3M™ Transbond™ Orthodontic Adhesive approved by the FDA?

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

What company makes 3M™ Transbond™ Orthodontic Adhesive?

3M™ Transbond™ Orthodontic Adhesive is manufactured by 3M Unitek Orthodontic Products.

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

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

Related Clinical Trials

Related Devices (Code: DYH)

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.