K-number	K210977
Device name	E-Dent 1000
Applicant	Envisiontec GmbH
Product code	EBF
Device class	Class II
Decision date	May 25, 2021
Decision	Substantially Equivalent
Regulation	872.3690

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Source

View the full FDA submission: accessdata.fda.gov

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E-Dent 1000

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