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FDA 510(k)

CAULK PRISMA-LITE

K-Number: K801588 · 1980-09-16

ApplicantDentsply Intl.
Decision Date1980-09-16
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CAULK PRISMA-LITE is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1980-09-16 under 510(k) number K801588. 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 CAULK PRISMA-LITE?

CAULK PRISMA-LITE is a medical device that received FDA 510(k) clearance on 1980-09-16. The listed applicant is Dentsply Intl.. The 510(k) number is K801588.

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

CAULK PRISMA-LITE received FDA 510(k) clearance on 1980-09-16, under 510(k) number K801588.

Who is the listed applicant for CAULK PRISMA-LITE?

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 CAULK PRISMA-LITE?

The FDA product code for CAULK PRISMA-LITE is EBZ.

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Related Devices (Code: EBZ)

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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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