Name: Predicase
Price: 199 USD

K-number	K180562
Device name	TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT
Applicant	Zirkonzahn GmbH
Product code	EBG
Device class	Class II
Decision date	Jun 28, 2018
Decision	Substantially Equivalent
Regulation	872.3770

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Source

View the full FDA submission: accessdata.fda.gov

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TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT

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