FDA 510(k)

PuRE PMMA Disc

K-Number: K201563 · 2021-04-09

Decision Date2021-04-09

Product CodeEBG

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

PuRE PMMA Disc is the device name listed in this FDA 510(k) record. The listed applicant is Quest Dental USA Corp.. It received FDA 510(k) clearance on 2021-04-09 under 510(k) number K201563. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PuRE PMMA Disc?

PuRE PMMA Disc is a medical device that received FDA 510(k) clearance on 2021-04-09. The listed applicant is Quest Dental USA Corp.. The 510(k) number is K201563.

When did PuRE PMMA Disc receive FDA 510(k) clearance?

PuRE PMMA Disc received FDA 510(k) clearance on 2021-04-09, under 510(k) number K201563.

Who is the listed applicant for PuRE PMMA Disc?

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

What is the FDA product code for PuRE PMMA Disc?

The FDA product code for PuRE PMMA Disc is EBG.

Other records listing Quest Dental USA Corp. as applicant

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.

K172281PuRE PMMA Disc

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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.