K-number	K172560
Device name	PREMIUM ONE Implant Systems
Applicant	Sweden & Martina S.P.A.
Product code	DZE
Device class	Class II
Decision date	Dec 21, 2017
Decision	Substantially Equivalent
Regulation	872.3640

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Source

View the full FDA submission: accessdata.fda.gov

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PREMIUM ONE Implant Systems

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