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FDA 510(k)

PRISMA-FINE

K-Number: K830442 · 1983-03-17

ApplicantDentsply Intl.
Decision Date1983-03-17
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PRISMA-FINE is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1983-03-17 under 510(k) number K830442. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRISMA-FINE?

PRISMA-FINE is a medical device that received FDA 510(k) clearance on 1983-03-17. The listed applicant is Dentsply Intl.. The 510(k) number is K830442.

When did PRISMA-FINE receive FDA 510(k) clearance?

PRISMA-FINE received FDA 510(k) clearance on 1983-03-17, under 510(k) number K830442.

Who is the listed applicant for PRISMA-FINE?

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-FINE?

The FDA product code for PRISMA-FINE is EBF.

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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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