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FDA 510(k)

3M™ Clarity™Aligners with Quick Attachments

K-Number: K233257 · 2023-09-29

Applicant3M Company, Unitek Orthodontic Products
Decision Date2023-09-29
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

3M™ Clarity™Aligners with Quick Attachments 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 2023-09-29 under 510(k) number K233257. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3M™ Clarity™Aligners with Quick Attachments?

3M™ Clarity™Aligners with Quick Attachments is a medical device that received FDA 510(k) clearance on 2023-09-29. The listed applicant is 3M Company, Unitek Orthodontic Products. The 510(k) number is K233257.

When did 3M™ Clarity™Aligners with Quick Attachments receive FDA 510(k) clearance?

3M™ Clarity™Aligners with Quick Attachments received FDA 510(k) clearance on 2023-09-29, under 510(k) number K233257.

Who is the listed applicant for 3M™ Clarity™Aligners with Quick Attachments?

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 with Quick Attachments?

The FDA product code for 3M™ Clarity™Aligners with Quick Attachments is NXC.

Other records listing 3M Company, Unitek Orthodontic Products 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.

K2314643M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force, 3M™ Clarity™ Aligners-Flex)K2111903M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)

Related Devices (Code: NXC)

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.

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) LimitedK250739Primeprint Direct AlignerDreve Dentamid GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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