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FDA 510(k)

PLASTICEPH

K-Number: K810538 · 1981-04-29

ApplicantMorningstar Dental Co.
Decision Date1981-04-29
Product CodeEAG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PLASTICEPH is the device name listed in this FDA 510(k) record. The listed applicant is Morningstar Dental Co.. It received FDA 510(k) clearance on 1981-04-29 under 510(k) number K810538. The device is classified under product code EAG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLASTICEPH?

PLASTICEPH is a medical device that received FDA 510(k) clearance on 1981-04-29. The listed applicant is Morningstar Dental Co.. The 510(k) number is K810538.

When did PLASTICEPH receive FDA 510(k) clearance?

PLASTICEPH received FDA 510(k) clearance on 1981-04-29, under 510(k) number K810538.

Who is the listed applicant for PLASTICEPH?

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

What is the FDA product code for PLASTICEPH?

The FDA product code for PLASTICEPH is EAG.

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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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