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FDA 510(k)

EVOLUX CAD/CAM PMMA BLOCKS

K-Number: K182065 · 2018-12-13

ApplicantBlue Dent Dental
Decision Date2018-12-13
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EVOLUX CAD/CAM PMMA BLOCKS is a medical device manufactured by Blue Dent Dental. It received FDA 510(k) clearance on 2018-12-13 under approval number K182065. 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 EVOLUX CAD/CAM PMMA BLOCKS?

EVOLUX CAD/CAM PMMA BLOCKS is a medical device that received FDA 510(k) clearance on 2018-12-13. It is manufactured by Blue Dent Dental. The 510(k) number is K182065.

When was EVOLUX CAD/CAM PMMA BLOCKS approved by the FDA?

EVOLUX CAD/CAM PMMA BLOCKS received FDA 510(k) clearance on 2018-12-13, under approval number K182065.

What company makes EVOLUX CAD/CAM PMMA BLOCKS?

EVOLUX CAD/CAM PMMA BLOCKS is manufactured by Blue Dent Dental.

What is the FDA product code for EVOLUX CAD/CAM PMMA BLOCKS?

The FDA product code for EVOLUX CAD/CAM PMMA BLOCKS is EBG.

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 K172281PuRE PMMA DiscQuest Dental USA Corp.

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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