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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 the device name listed in this FDA 510(k) record. The listed applicant is Premier Dental Products Company. It received FDA 510(k) clearance on 2022-12-06 under 510(k) 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. The listed applicant is Premier Dental Products Company. The 510(k) number is K223632.

When did Premier's MultiMatch Universal Chameleon Restorative Composite receive FDA 510(k) clearance?

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

Who is the listed applicant for Premier's MultiMatch Universal Chameleon Restorative Composite?

The FDA 510(k) record lists Premier Dental Products Company as the applicant. This does not by itself establish the device manufacturer.

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

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.

NCT076337173-D Printed Resin Composite Versus Milled Resin Composite and Hybrid Ceramic Onlays: 2-Year Clinical Performance, Microtensile Bond Strength, Marginal and Internal AdaptationACTIVE_NOT_RECRUITING

Other records listing Premier Dental Products Company 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.

K260682Bond-PR™ Universal AdhesiveK253513MultiMatch Flow Chameleon AntiMicrobial Composite

Related Devices (Code: EBF)

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.

K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K261246SRGC-06GC America, Inc.K261093DIAFILDiaDent Group InternationalK261071DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)DiaDent Group InternationalK260805Dual CoreVericom Co., Ltd.

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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