Name: Predicase
Price: 199 USD

K-number	K182620
Device name	MRI Compatibility for Existing Neodent Implant System
Applicant	Jjgc Industria E Comercio DE Materiais Dentarios S.A.
Product code	DZE
Device class	Class II
Decision date	Jan 18, 2019
Decision	Substantially Equivalent
Regulation	872.3640

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Source

View the full FDA submission: accessdata.fda.gov

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MRI Compatibility for Existing Neodent Implant System

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