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FDA 510(k)

COMPOSITE ALIGNER BUTTON

K-Number: K080246 · 2008-04-11

ApplicantDentsply Interntional
Decision Date2008-04-11
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

COMPOSITE ALIGNER BUTTON is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Interntional. It received FDA 510(k) clearance on 2008-04-11 under 510(k) number K080246. 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 COMPOSITE ALIGNER BUTTON?

COMPOSITE ALIGNER BUTTON is a medical device that received FDA 510(k) clearance on 2008-04-11. The listed applicant is Dentsply Interntional. The 510(k) number is K080246.

When did COMPOSITE ALIGNER BUTTON receive FDA 510(k) clearance?

COMPOSITE ALIGNER BUTTON received FDA 510(k) clearance on 2008-04-11, under 510(k) number K080246.

Who is the listed applicant for COMPOSITE ALIGNER BUTTON?

The FDA 510(k) record lists Dentsply Interntional as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COMPOSITE ALIGNER BUTTON?

The FDA product code for COMPOSITE ALIGNER BUTTON is NXC.

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Other records listing Dentsply Interntional 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.

K092614X-SMART EASYK092030ELATION MB METAL REINFORCED PLASTIC BRACKETK090454ALLURE MB CERAMIC BRACKETSK082973STER-MATE STERILE LAVAGE KITK082974MYSTIQUE MB CERAMIC BRACKETSK081291PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION

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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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