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FDA 510(k)

PuRE PMMA Disc

K-Number: K172281 · 2017-10-19

ApplicantQuest Dental USA Corp.
Decision Date2017-10-19
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 2017-10-19 under approval number K172281. 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 2017-10-19. It is manufactured by Quest Dental USA Corp.. The 510(k) number is K172281.

When was PuRE PMMA Disc approved by the FDA?

PuRE PMMA Disc received FDA 510(k) clearance on 2017-10-19, under approval number K172281.

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.

K201563PuRE PMMA Disc

Related Devices (Code: EBG)

K153490DD medical polymersDental Direkt GmbH K152443Vericore Gradient Temporary DiscWhip Mix Corporation K153753TelioCAD MultiIvoclar Vivadent, Inc. K152215DENTALOS PLUS MONO, DENTALOS PLUS MULTICOLORDentalplus GmbH K171729Fixtemp C&BDreve Dentamid GmbH K182065EVOLUX CAD/CAM PMMA BLOCKSBlue Dent Dental

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.

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