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FDA 510(k)

BEAUTIFIL OPAQUER

K-Number: K080068 · 2008-02-28

ApplicantShofu Dental Corp.
Decision Date2008-02-28
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BEAUTIFIL OPAQUER is the device name listed in this FDA 510(k) record. The listed applicant is Shofu Dental Corp.. It received FDA 510(k) clearance on 2008-02-28 under 510(k) number K080068. 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 OPAQUER?

BEAUTIFIL OPAQUER is a medical device that received FDA 510(k) clearance on 2008-02-28. The listed applicant is Shofu Dental Corp.. The 510(k) number is K080068.

When did BEAUTIFIL OPAQUER receive FDA 510(k) clearance?

BEAUTIFIL OPAQUER received FDA 510(k) clearance on 2008-02-28, under 510(k) number K080068.

Who is the listed applicant for BEAUTIFIL OPAQUER?

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

What is the FDA product code for BEAUTIFIL OPAQUER?

The FDA product code for BEAUTIFIL OPAQUER is EBF.

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Other records listing Shofu Dental Corp. 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.

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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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