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FDA 510(k)

OPAQUE PORCELAIN

K-Number: K900393 · 1990-04-16

ApplicantDentsply Intl.
Decision Date1990-04-16
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OPAQUE PORCELAIN is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1990-04-16 under 510(k) number K900393. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPAQUE PORCELAIN?

OPAQUE PORCELAIN is a medical device that received FDA 510(k) clearance on 1990-04-16. The listed applicant is Dentsply Intl.. The 510(k) number is K900393.

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

OPAQUE PORCELAIN received FDA 510(k) clearance on 1990-04-16, under 510(k) number K900393.

Who is the listed applicant for OPAQUE PORCELAIN?

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

What is the FDA product code for OPAQUE PORCELAIN?

The FDA product code for OPAQUE PORCELAIN is EIH.

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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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