K-number	K162848
Device name	Straumann CARES Golden Ti/TiN Abutments
Applicant	Institut Straumann AG
Product code	NHA
Device class	Class II
Decision date	Sep 22, 2017
Decision	Substantially Equivalent
Regulation	872.3630

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Source

View the full FDA submission: accessdata.fda.gov

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Straumann CARES Golden Ti/TiN Abutments

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