Name: Predicase
Price: 199 USD

K-number	K181703
Device name	Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments
Applicant	Institut Straumann AG
Product code	DZE
Device class	Class II
Decision date	Dec 28, 2018
Decision	Substantially Equivalent
Regulation	872.3640

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Source

View the full FDA submission: accessdata.fda.gov

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Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments

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