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FDA 510(k)

BeautiCem Veneer Kit

K-Number: K180649 · 2018-06-11

ApplicantShofu Dental Corporation
Decision Date2018-06-11
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BeautiCem Veneer Kit is the device name listed in this FDA 510(k) record. The listed applicant is Shofu Dental Corporation. It received FDA 510(k) clearance on 2018-06-11 under 510(k) number K180649. 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 BeautiCem Veneer Kit?

BeautiCem Veneer Kit is a medical device that received FDA 510(k) clearance on 2018-06-11. The listed applicant is Shofu Dental Corporation. The 510(k) number is K180649.

When did BeautiCem Veneer Kit receive FDA 510(k) clearance?

BeautiCem Veneer Kit received FDA 510(k) clearance on 2018-06-11, under 510(k) number K180649.

Who is the listed applicant for BeautiCem Veneer Kit?

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

What is the FDA product code for BeautiCem Veneer Kit?

The FDA product code for BeautiCem Veneer Kit is EBF.

Other records listing Shofu Dental Corporation 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.

K252808GlasIonomer FX-LCK252165ZIRCONOMER PK251470ResiCem EXK251578BEAUTIFIL IIK233161BeautiLink SAK222253GlasIonomer FX ULTRA

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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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