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FDA 510(k)

BEAUTIFIL BULK FLOWABLE

K-Number: K132141 · 2013-10-03

ApplicantShofu Dental Corporation
Decision Date2013-10-03
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BEAUTIFIL BULK FLOWABLE 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 2013-10-03 under 510(k) number K132141. 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 BEAUTIFIL BULK FLOWABLE?

BEAUTIFIL BULK FLOWABLE is a medical device that received FDA 510(k) clearance on 2013-10-03. The listed applicant is Shofu Dental Corporation. The 510(k) number is K132141.

When did BEAUTIFIL BULK FLOWABLE receive FDA 510(k) clearance?

BEAUTIFIL BULK FLOWABLE received FDA 510(k) clearance on 2013-10-03, under 510(k) number K132141.

Who is the listed applicant for BEAUTIFIL BULK FLOWABLE?

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 BEAUTIFIL BULK FLOWABLE?

The FDA product code for BEAUTIFIL BULK FLOWABLE is EBF.

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Other records listing Shofu Dental Corporation as applicant

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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.

K262982Core·it DualSpident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261246SRGC-06GC America, Inc.

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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