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FDA 510(k)

IMPROVED DYCAL

K-Number: K820215 · 1982-03-23

ApplicantDentsply Intl.
Decision Date1982-03-23
Product CodeEJK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IMPROVED DYCAL is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1982-03-23 under 510(k) number K820215. The device is classified under product code EJK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPROVED DYCAL?

IMPROVED DYCAL is a medical device that received FDA 510(k) clearance on 1982-03-23. The listed applicant is Dentsply Intl.. The 510(k) number is K820215.

When did IMPROVED DYCAL receive FDA 510(k) clearance?

IMPROVED DYCAL received FDA 510(k) clearance on 1982-03-23, under 510(k) number K820215.

Who is the listed applicant for IMPROVED DYCAL?

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 IMPROVED DYCAL?

The FDA product code for IMPROVED DYCAL is EJK.

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Related Devices (Code: EJK)

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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