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FDA 510(k)

BEAUTIFIL E POSTERIOR, BEAUTIFIL BULK

K-Number: K132748 · 2013-12-04

ApplicantShofu Dental Corporation
Decision Date2013-12-04
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BEAUTIFIL E POSTERIOR, BEAUTIFIL BULK 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 2013-12-04 under 510(k) number K132748. 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 E POSTERIOR, BEAUTIFIL BULK?

BEAUTIFIL E POSTERIOR, BEAUTIFIL BULK is a medical device that received FDA 510(k) clearance on 2013-12-04. The listed applicant is Shofu Dental Corporation. The 510(k) number is K132748.

When did BEAUTIFIL E POSTERIOR, BEAUTIFIL BULK receive FDA 510(k) clearance?

BEAUTIFIL E POSTERIOR, BEAUTIFIL BULK received FDA 510(k) clearance on 2013-12-04, under 510(k) number K132748.

Who is the listed applicant for BEAUTIFIL E POSTERIOR, BEAUTIFIL BULK?

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 E POSTERIOR, BEAUTIFIL BULK?

The FDA product code for BEAUTIFIL E POSTERIOR, BEAUTIFIL BULK is EBF.

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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.

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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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