FDA 510(k)

PRE-DENT

K-Number: K791200 · 1979-08-10

Decision Date1979-08-10

Product CodeGIM

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

PRE-DENT is the device name listed in this FDA 510(k) record. The listed applicant is Fichte, Graves, and Hunt. It received FDA 510(k) clearance on 1979-08-10 under 510(k) number K791200. The device is classified under product code GIM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRE-DENT?

PRE-DENT is a medical device that received FDA 510(k) clearance on 1979-08-10. The listed applicant is Fichte, Graves, and Hunt. The 510(k) number is K791200.

When did PRE-DENT receive FDA 510(k) clearance?

PRE-DENT received FDA 510(k) clearance on 1979-08-10, under 510(k) number K791200.

Who is the listed applicant for PRE-DENT?

The FDA 510(k) record lists Fichte, Graves, and Hunt as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRE-DENT?

The FDA product code for PRE-DENT is GIM.

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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.