Home / 510(k) Clearances / K182615

510(k) K182615

Surgikor Dental Implant System by Surgikor, LLC — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 2019
Date Received
September 21, 2018
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 Surgikor, LLC

  • K240803 — Surgikor Fixation One, Abutment Blanks and Abutments (September 12, 2024)

Other clearances for product code DZE

  • K252031 — Adin Long Dental Implant System (March 23, 2026)
  • K253334 — ZENEX Implant System_Short (R-System) (March 16, 2026)
  • 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)