FDA 510(k)

PORCELITE DUAL CURE CEMENT

K-Number: K880685 · 1988-05-11

Decision Date1988-05-11

Product CodeEMA

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

PORCELITE DUAL CURE CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Kerr Corporation (Danbury). It received FDA 510(k) clearance on 1988-05-11 under 510(k) number K880685. 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 PORCELITE DUAL CURE CEMENT?

PORCELITE DUAL CURE CEMENT is a medical device that received FDA 510(k) clearance on 1988-05-11. The listed applicant is Kerr Corporation (Danbury). The 510(k) number is K880685.

When did PORCELITE DUAL CURE CEMENT receive FDA 510(k) clearance?

PORCELITE DUAL CURE CEMENT received FDA 510(k) clearance on 1988-05-11, under 510(k) number K880685.

Who is the listed applicant for PORCELITE DUAL CURE CEMENT?

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

What is the FDA product code for PORCELITE DUAL CURE CEMENT?

The FDA product code for PORCELITE DUAL CURE CEMENT 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.