FDA 510(k)

Fixtemp C&B

K-Number: K171729 · 2017-12-13

Decision Date2017-12-13

Product CodeEBG

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Fixtemp C&B is a medical device manufactured by Dreve Dentamid GmbH. It received FDA 510(k) clearance on 2017-12-13 under approval number K171729. 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 Fixtemp C&B?

Fixtemp C&B is a medical device that received FDA 510(k) clearance on 2017-12-13. It is manufactured by Dreve Dentamid GmbH. The 510(k) number is K171729.

When was Fixtemp C&B approved by the FDA?

Fixtemp C&B received FDA 510(k) clearance on 2017-12-13, under approval number K171729.

What company makes Fixtemp C&B?

Fixtemp C&B is manufactured by Dreve Dentamid GmbH.

What is the FDA product code for Fixtemp C&B?

The FDA product code for Fixtemp C&B is EBG.

Other Devices by Dreve Dentamid GmbH

K171562Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono K162408Nano Varnish, Plaquit, Lightpaint on Surface K190571StoneBite and StoneBite scan K200580FotoDent denture K250739Primeprint Direct Aligner

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 K172281PuRE PMMA DiscQuest Dental USA Corp. K182065EVOLUX CAD/CAM PMMA BLOCKSBlue Dent Dental

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.