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FDA 510(k)

PRISMA III

K-Number: K832320 · 1983-08-31

Decision Date1983-08-31
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PRISMA III is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1983-08-31 under 510(k) number K832320. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRISMA III?

PRISMA III is a medical device that received FDA 510(k) clearance on 1983-08-31. The listed applicant is Dentsply Intl.. The 510(k) number is K832320.

When did PRISMA III receive FDA 510(k) clearance?

PRISMA III received FDA 510(k) clearance on 1983-08-31, under 510(k) number K832320.

Who is the listed applicant for PRISMA III?

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 III?

The FDA product code for PRISMA III is EBZ.

Related Clinical Trials

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.

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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Related Devices (Code: EBZ)

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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