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510(k) K201225

Neodent Implant System - GM Helix Implants 7.0 by Jjgc Industria E Comercio DE Materiais Dentarios S.A. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 2020
Date Received
May 6, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Endosseous, Root-Form
Device Class
Class II
Regulation Number
872.3640
Review Panel
DE
Submission Type

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