K-number	K232487
Device name	Provecta 3D Prime and Provecta 3D Prime Ceph
Applicant	Durr Dental SE
Product code	OAS
Device class	Class II
Decision date	Sep 14, 2023
Decision	Substantially Equivalent
Regulation	892.1750

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Source

View the full FDA submission: accessdata.fda.gov

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Provecta 3D Prime and Provecta 3D Prime Ceph

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