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FDA 510(k)

METACEM, META P&BOND, METACEM SILANE CERAMIC PRIMER

K-Number: K081913 · 2008-09-05

ApplicantMeta Biomed Co., Ltd.
Decision Date2008-09-05
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

METACEM, META P&BOND, METACEM SILANE CERAMIC PRIMER is the device name listed in this FDA 510(k) record. The listed applicant is Meta Biomed Co., Ltd.. It received FDA 510(k) clearance on 2008-09-05 under 510(k) number K081913. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the METACEM, META P&BOND, METACEM SILANE CERAMIC PRIMER?

METACEM, META P&BOND, METACEM SILANE CERAMIC PRIMER is a medical device that received FDA 510(k) clearance on 2008-09-05. The listed applicant is Meta Biomed Co., Ltd.. The 510(k) number is K081913.

When did METACEM, META P&BOND, METACEM SILANE CERAMIC PRIMER receive FDA 510(k) clearance?

METACEM, META P&BOND, METACEM SILANE CERAMIC PRIMER received FDA 510(k) clearance on 2008-09-05, under 510(k) number K081913.

Who is the listed applicant for METACEM, META P&BOND, METACEM SILANE CERAMIC PRIMER?

The FDA 510(k) record lists Meta Biomed Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for METACEM, META P&BOND, METACEM SILANE CERAMIC PRIMER?

The FDA product code for METACEM, META P&BOND, METACEM SILANE CERAMIC PRIMER is EMA.

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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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