E-Dent 1000— 510(k) K210977

Substantially Equivalent

Envisiontec GmbH

FDA 510(k) clearance K210977 for E-Dent 1000, Substantially Equivalent on 2021-05-25. Applicant: Envisiontec GmbH. Device class: 2.

Clearance details

Applicant: Envisiontec GmbH
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2021-04-01
Decision date: 2021-05-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gladbeck, DE

Download summary PDF View on FDA.gov ↗

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