Name: Predicase
Price: 199 USD

K-number	K214051
Device name	Neodent Implant System-Helix NGM Compact Surgical Kit Cases
Applicant	JJGC Indústria e Comércio de Materiais Dentários S.A.
Product code	KCT
Device class	Class II
Decision date	Apr 13, 2022
Decision	Substantially Equivalent
Regulation	880.6850

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Source

View the full FDA submission: accessdata.fda.gov

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Neodent Implant System-Helix NGM Compact Surgical Kit Cases

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