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FDA 510(k)

BeautiCem Veneer Kit

K-Number: K180649 · 2018-06-11

Decision Date2018-06-11
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BeautiCem Veneer Kit is a medical device manufactured by Shofu Dental Corporation. It received FDA 510(k) clearance on 2018-06-11 under approval 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. It is manufactured by Shofu Dental Corporation. The 510(k) number is K180649.

When was BeautiCem Veneer Kit approved by the FDA?

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

What company makes BeautiCem Veneer Kit?

BeautiCem Veneer Kit is manufactured by Shofu Dental Corporation.

What is the FDA product code for BeautiCem Veneer Kit?

The FDA product code for BeautiCem Veneer Kit is EBF.

Other Devices by Shofu Dental Corporation

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Related Devices (Code: EBF)

Official Source

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