K-number	K213562
Device name	DTX Studio Clinic 3.0
Applicant	Nobel Biocare AB
Product code	LLZ
Device class	Class II
Decision date	Mar 25, 2022
Decision	Substantially Equivalent
Regulation	892.2050

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Source

View the full FDA submission: accessdata.fda.gov

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DTX Studio Clinic 3.0

Everything you need for a 510(k) submission. Nothing you don't.