E-Dent 1000
K-Number: K210977 · 2021-05-25
ApplicantEnvisiontec GmbH
Decision Date2021-05-25
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
E-Dent 1000 is a medical device manufactured by Envisiontec GmbH. It received FDA 510(k) clearance on 2021-05-25 under approval number K210977. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the E-Dent 1000?
E-Dent 1000 is a medical device that received FDA 510(k) clearance on 2021-05-25. It is manufactured by Envisiontec GmbH. The 510(k) number is K210977.
When was E-Dent 1000 approved by the FDA?
E-Dent 1000 received FDA 510(k) clearance on 2021-05-25, under approval number K210977.
What company makes E-Dent 1000?
E-Dent 1000 is manufactured by Envisiontec GmbH.
What is the FDA product code for E-Dent 1000?
The FDA product code for E-Dent 1000 is EBF.
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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.