Home / 510(k) Clearances / K233896

510(k) K233896

JDentalCare Dental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plus by Jdentalcare Srl — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2024
Date Received
December 11, 2023
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

  • K251148 — JDEvolution Plus L and JDEvolution Plus LE (September 25, 2025)
  • K240143 — JDZygoma dental implants (October 11, 2024)
  • K182081 — JDentalCare Implant System JDIcon (June 26, 2020)
  • K143142 — JDENTALCARE Implant System (November 6, 2015)

Other clearances for product code DZE

  • K252168 — Straumann® BLC Implants - Indication Widening (March 10, 2026)
  • K253493 — Dentis SQ-SL AXEL Fixture (March 4, 2026)
  • K252197 — Nobel Biocare S Series Implants (February 18, 2026)
  • K252286 — BIORES Dental Implant System (February 2, 2026)
  • K252585 — ZENEX Implant System_R-System (January 8, 2026)
  • K250476 — NizPlant Dental Implant System (December 23, 2025)
  • K252145 — GEN5™ and GEN5+™ 3.3mmD Dental Implants (December 23, 2025)
  • K251605 — DIMPLO Implant System (December 22, 2025)
  • K252090 — Pterygoid Indication for GM Helix Implants (December 12, 2025)
  • K251129 — S.I.N. Tapered Pro Conical Zygoma Implant System (November 7, 2025)