Name: Predicase
Price: 199 USD

K-number	K193592
Device name	Neodent Implant System - Change in the Shelf Life of Neodent Acqua Implants
Applicant	Jjgc Industria E Comercio DE Materiais Dentarios S.A.
Product code	DZE
Device class	Class II
Decision date	Apr 28, 2020
Decision	Substantially Equivalent
Regulation	872.3640

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Source

View the full FDA submission: accessdata.fda.gov

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Neodent Implant System - Change in the Shelf Life of Neodent Acqua Implants

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