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FDA 510(k)

DISTAFLEX

K-Number: K823280 · 1982-11-22

ApplicantDuradent Corp.
Decision Date1982-11-22
Product CodeEGG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DISTAFLEX is the device name listed in this FDA 510(k) record. The listed applicant is Duradent Corp.. It received FDA 510(k) clearance on 1982-11-22 under 510(k) number K823280. The device is classified under product code EGG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISTAFLEX?

DISTAFLEX is a medical device that received FDA 510(k) clearance on 1982-11-22. The listed applicant is Duradent Corp.. The 510(k) number is K823280.

When did DISTAFLEX receive FDA 510(k) clearance?

DISTAFLEX received FDA 510(k) clearance on 1982-11-22, under 510(k) number K823280.

Who is the listed applicant for DISTAFLEX?

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

What is the FDA product code for DISTAFLEX?

The FDA product code for DISTAFLEX is EGG.

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Related Devices (Code: EGG)

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

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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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