FDA 510(k)

FotoDent denture

K-Number: K200580 · 2020-11-19

Decision Date2020-11-19

Product CodeEBI

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

FotoDent denture is a medical device manufactured by Dreve Dentamid GmbH. It received FDA 510(k) clearance on 2020-11-19 under approval number K200580. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FotoDent denture?

FotoDent denture is a medical device that received FDA 510(k) clearance on 2020-11-19. It is manufactured by Dreve Dentamid GmbH. The 510(k) number is K200580.

When was FotoDent denture approved by the FDA?

FotoDent denture received FDA 510(k) clearance on 2020-11-19, under approval number K200580.

What company makes FotoDent denture?

FotoDent denture is manufactured by Dreve Dentamid GmbH.

What is the FDA product code for FotoDent denture?

The FDA product code for FotoDent denture is EBI.

Other Devices by Dreve Dentamid GmbH

K171729Fixtemp C&B K171562Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono K162408Nano Varnish, Plaquit, Lightpaint on Surface K190571StoneBite and StoneBite scan K250739Primeprint Direct Aligner

Related Devices (Code: EBI)

K161330Pour AcrylicDentsply Sirona K153546PINK CAD/CAM discPolident D.O.O., Dental Products Industry K152981JET SET 4 DENTURE REPAIR RESINLang Dental Manufacturing Company, Inc. K160498Dentivera Milling DiscDental Solutions, LLC K153590AvaDent Denture Base MaterialGlobal Dental Science K152051ClearMetMycone Dental Supply Co., T/A Keystone Industries

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.