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FDA 510(k)

UNIVERSAL OPAQUE

K-Number: K131504 · 2013-07-16

ApplicantShofu Dental Corporation
Decision Date2013-07-16
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

UNIVERSAL OPAQUE 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 2013-07-16 under 510(k) number K131504. 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 UNIVERSAL OPAQUE?

UNIVERSAL OPAQUE is a medical device that received FDA 510(k) clearance on 2013-07-16. The listed applicant is Shofu Dental Corporation. The 510(k) number is K131504.

When did UNIVERSAL OPAQUE receive FDA 510(k) clearance?

UNIVERSAL OPAQUE received FDA 510(k) clearance on 2013-07-16, under 510(k) number K131504.

Who is the listed applicant for UNIVERSAL OPAQUE?

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 UNIVERSAL OPAQUE?

The FDA product code for UNIVERSAL OPAQUE 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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