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FDA 510(k)

SHOFU BLOCK HC

K-Number: K130841 · 2013-09-11

ApplicantShofu Dental Corporation
Decision Date2013-09-11
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SHOFU BLOCK HC 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 2013-09-11 under 510(k) number K130841. 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 SHOFU BLOCK HC?

SHOFU BLOCK HC is a medical device that received FDA 510(k) clearance on 2013-09-11. The listed applicant is Shofu Dental Corporation. The 510(k) number is K130841.

When did SHOFU BLOCK HC receive FDA 510(k) clearance?

SHOFU BLOCK HC received FDA 510(k) clearance on 2013-09-11, under 510(k) number K130841.

Who is the listed applicant for SHOFU BLOCK HC?

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 SHOFU BLOCK HC?

The FDA product code for SHOFU BLOCK HC is EBF.

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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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