Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

E-Denture Pro

K-Number: K203641 · 2021-03-30

ApplicantEnvisiontec GmbH
Decision Date2021-03-30
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

E-Denture Pro is a medical device manufactured by Envisiontec GmbH. It received FDA 510(k) clearance on 2021-03-30 under approval number K203641. 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 E-Denture Pro?

E-Denture Pro is a medical device that received FDA 510(k) clearance on 2021-03-30. It is manufactured by Envisiontec GmbH. The 510(k) number is K203641.

When was E-Denture Pro approved by the FDA?

E-Denture Pro received FDA 510(k) clearance on 2021-03-30, under approval number K203641.

What company makes E-Denture Pro?

E-Denture Pro is manufactured by Envisiontec GmbH.

What is the FDA product code for E-Denture Pro?

The FDA product code for E-Denture Pro is EBI.

Other Devices by Envisiontec GmbH

K201173E-Guard K211101E-Temp K210977E-Dent 1000 K220894SmileGuard

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑