PuRE PMMA Disc
K-Number: K201563 · 2021-04-09
ApplicantQuest Dental USA Corp.
Decision Date2021-04-09
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
PuRE PMMA Disc is a medical device manufactured by Quest Dental USA Corp.. It received FDA 510(k) clearance on 2021-04-09 under approval 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. It is manufactured by Quest Dental USA Corp.. The 510(k) number is K201563.
When was PuRE PMMA Disc approved by the FDA?
PuRE PMMA Disc received FDA 510(k) clearance on 2021-04-09, under approval number K201563.
What company makes PuRE PMMA Disc?
PuRE PMMA Disc is manufactured by Quest Dental USA Corp..
What is the FDA product code for PuRE PMMA Disc?
The FDA product code for PuRE PMMA Disc is EBG.
Other Devices by Quest Dental USA Corp.
Related Devices (Code: EBG)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.