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FDA 510(k)

PFZ PORCELAIN SYSTEM

K-Number: K033553 · 2003-12-02

ApplicantDentsply Intl.
Decision Date2003-12-02
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PFZ PORCELAIN SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 2003-12-02 under 510(k) number K033553. 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 PFZ PORCELAIN SYSTEM?

PFZ PORCELAIN SYSTEM is a medical device that received FDA 510(k) clearance on 2003-12-02. The listed applicant is Dentsply Intl.. The 510(k) number is K033553.

When did PFZ PORCELAIN SYSTEM receive FDA 510(k) clearance?

PFZ PORCELAIN SYSTEM received FDA 510(k) clearance on 2003-12-02, under 510(k) number K033553.

Who is the listed applicant for PFZ PORCELAIN SYSTEM?

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 PFZ PORCELAIN SYSTEM?

The FDA product code for PFZ PORCELAIN SYSTEM 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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