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FDA 510(k)

INSURE PORCELAIN VENEER BONDING SYSTEM

K-Number: K873356 · 1987-12-29

ApplicantCosmedent, Inc.
Decision Date1987-12-29
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

INSURE PORCELAIN VENEER BONDING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cosmedent, Inc.. It received FDA 510(k) clearance on 1987-12-29 under 510(k) number K873356. 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 INSURE PORCELAIN VENEER BONDING SYSTEM?

INSURE PORCELAIN VENEER BONDING SYSTEM is a medical device that received FDA 510(k) clearance on 1987-12-29. The listed applicant is Cosmedent, Inc.. The 510(k) number is K873356.

When did INSURE PORCELAIN VENEER BONDING SYSTEM receive FDA 510(k) clearance?

INSURE PORCELAIN VENEER BONDING SYSTEM received FDA 510(k) clearance on 1987-12-29, under 510(k) number K873356.

Who is the listed applicant for INSURE PORCELAIN VENEER BONDING SYSTEM?

The FDA 510(k) record lists Cosmedent, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INSURE PORCELAIN VENEER BONDING SYSTEM?

The FDA product code for INSURE PORCELAIN VENEER BONDING SYSTEM is EMA.

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Related Devices (Code: 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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