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510(k) K190718

Zygomatic Implants by Jjgc Industria E Comercio DE Materiais Dentarios S.A. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 2019
Date Received
March 20, 2019
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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