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FDA 510(k)

PANAGRAF

K-Number: K862829 · 1986-09-19

ApplicantPanadent International, Inc.
Decision Date1986-09-19
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PANAGRAF is the device name listed in this FDA 510(k) record. The listed applicant is Panadent International, Inc.. It received FDA 510(k) clearance on 1986-09-19 under 510(k) number K862829. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PANAGRAF?

PANAGRAF is a medical device that received FDA 510(k) clearance on 1986-09-19. The listed applicant is Panadent International, Inc.. The 510(k) number is K862829.

When did PANAGRAF receive FDA 510(k) clearance?

PANAGRAF received FDA 510(k) clearance on 1986-09-19, under 510(k) number K862829.

Who is the listed applicant for PANAGRAF?

The FDA 510(k) record lists Panadent International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PANAGRAF?

The FDA product code for PANAGRAF is KLE.

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Related Devices (Code: KLE)

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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