Home / 510(k) Clearances / K050586

510(k) K050586

LEONE IMPLANT SYSTEM by Leone S.P.A. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 2006
Date Received
March 7, 2005
Clearance Type
Abbreviated
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 Leone S.P.A.

  • K242944 — Leone Orthodontic Implant TAD (Temporary Anchorage Device) (June 19, 2025)
  • K071490 — LEONE ORTHODONTIC MINI IMPLANT (February 22, 2008)
  • K070483 — LEONE MONOIMPLANT FOR O-RING OVERDENTURE (April 19, 2007)

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)