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FDA 510(k)

PRISM-FINE

K-Number: K840652 · 1984-08-02

ApplicantDentsply Intl.
Decision Date1984-08-02
Product Code
DecisionSubstantially Equivalent

Device Summary

PRISM-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 1984-08-02 under 510(k) number K840652. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRISM-FINE?

PRISM-FINE is a medical device that received FDA 510(k) clearance on 1984-08-02. The listed applicant is Dentsply Intl.. The 510(k) number is K840652.

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

PRISM-FINE received FDA 510(k) clearance on 1984-08-02, under 510(k) number K840652.

Who is the listed applicant for PRISM-FINE?

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

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Other records listing Dentsply Intl. as applicant

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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