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510(k) K252145

GEN5™ and GEN5+™ 3.3mmD Dental Implants by Paragon Implant Mfg., LLC — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2025
Date Received
July 9, 2025
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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