FDA 510(k)

PRISMA METAL OPAQUERS

K-Number: K862660 · 1986-07-31

Decision Date1986-07-31

Product CodeEBC

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

PRISMA METAL OPAQUERS is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1986-07-31 under 510(k) number K862660. The device is classified under product code EBC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRISMA METAL OPAQUERS?

PRISMA METAL OPAQUERS is a medical device that received FDA 510(k) clearance on 1986-07-31. The listed applicant is Dentsply Intl.. The 510(k) number is K862660.

When did PRISMA METAL OPAQUERS receive FDA 510(k) clearance?

PRISMA METAL OPAQUERS received FDA 510(k) clearance on 1986-07-31, under 510(k) number K862660.

Who is the listed applicant for PRISMA METAL OPAQUERS?

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 PRISMA METAL OPAQUERS?

The FDA product code for PRISMA METAL OPAQUERS is EBC.

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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.