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510(k) K251148

JDEvolution Plus L and JDEvolution Plus LE by Jdentalcare Srl — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 2025
Date Received
April 14, 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

Other clearances by Jdentalcare Srl

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  • K182081 — JDentalCare Implant System JDIcon (June 26, 2020)
  • K143142 — JDENTALCARE Implant System (November 6, 2015)

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