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FDA 510(k)

PRG BARRIER COAT

K-Number: K122908 · 2013-04-26

ApplicantShofu Dental Corporation
Decision Date2013-04-26
Product CodeLBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PRG BARRIER COAT 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 2013-04-26 under 510(k) number K122908. The device is classified under product code LBH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRG BARRIER COAT?

PRG BARRIER COAT is a medical device that received FDA 510(k) clearance on 2013-04-26. The listed applicant is Shofu Dental Corporation. The 510(k) number is K122908.

When did PRG BARRIER COAT receive FDA 510(k) clearance?

PRG BARRIER COAT received FDA 510(k) clearance on 2013-04-26, under 510(k) number K122908.

Who is the listed applicant for PRG BARRIER COAT?

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 PRG BARRIER COAT?

The FDA product code for PRG BARRIER COAT is LBH.

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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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