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FDA 510(k)

Premier's MultiMatch Universal Chameleon Restorative Composite

K-Number: K223632 · 2022-12-06

ApplicantPremier Dental Products Company
Decision Date2022-12-06
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Premier's MultiMatch Universal Chameleon Restorative Composite is a medical device manufactured by Premier Dental Products Company. It received FDA 510(k) clearance on 2022-12-06 under approval number K223632. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Premier's MultiMatch Universal Chameleon Restorative Composite?

Premier's MultiMatch Universal Chameleon Restorative Composite is a medical device that received FDA 510(k) clearance on 2022-12-06. It is manufactured by Premier Dental Products Company. The 510(k) number is K223632.

When was Premier's MultiMatch Universal Chameleon Restorative Composite approved by the FDA?

Premier's MultiMatch Universal Chameleon Restorative Composite received FDA 510(k) clearance on 2022-12-06, under approval number K223632.

What company makes Premier's MultiMatch Universal Chameleon Restorative Composite?

Premier's MultiMatch Universal Chameleon Restorative Composite is manufactured by Premier Dental Products Company.

What is the FDA product code for Premier's MultiMatch Universal Chameleon Restorative Composite?

The FDA product code for Premier's MultiMatch Universal Chameleon Restorative Composite is EBF.

Related Clinical Trials

NCT07524842 Clinical Performance of Three Different Restorative Materials NOT_YET_RECRUITING NCT07261735 Clinical Evaluation of Customized Attachment Composites in Clear Aligner Therapy RECRUITING NCT05361746 Scotchbond Universal Plus Compared to Scotchbond Universal With Filtek Universal Restorative to Restore Class V NCCLs COMPLETED NCT07547904 Clinical Performance of Bioactive Bulk-Fill in Class II Restorations RECRUITING NCT07504393 Clinical Performance of Four Restorative Materials in Primary Molars NOT_YET_RECRUITING

Other Devices by Premier Dental Products Company

K253513MultiMatch Flow Chameleon AntiMicrobial Composite K260682Bond-PR™ Universal Adhesive

Related Devices (Code: EBF)

K163207Filtek One Bulk Fill Restorative3M Company K162537CAD/CAMouflage Milling BlockPrismatik Dentalcraft, Inc. K160049CharismaHeraeus Kulzer, LLC (Mitsui Chemicals Group) K162257P1145 Dental RestorativeKerr Corporation K151399Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq FlowSchutz Dental GmbH K162107TPH Spectra+ Universal Composite RestorativeDentsply Sirona

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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