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FDA 510(k)

DENTAL PORCELAIN

K-Number: K921619 · 1992-07-02

ApplicantDentsply Intl.
Decision Date1992-07-02
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTAL 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 1992-07-02 under 510(k) number K921619. 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 DENTAL PORCELAIN?

DENTAL PORCELAIN is a medical device that received FDA 510(k) clearance on 1992-07-02. The listed applicant is Dentsply Intl.. The 510(k) number is K921619.

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

DENTAL PORCELAIN received FDA 510(k) clearance on 1992-07-02, under 510(k) number K921619.

Who is the listed applicant for DENTAL 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 DENTAL PORCELAIN?

The FDA product code for DENTAL PORCELAIN is EIH.

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Related Devices (Code: EIH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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