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510(k) K203360

EK Implants and Abutments System by Hiossen, Inc. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 2022
Date Received
November 16, 2020
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 Hiossen, Inc.

  • K251427 — EK MULTI ANGLED 30 ABUTMENT (January 29, 2026)
  • K241003 — HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment) (January 8, 2025)
  • K240232 — EK D3.3 and Ultra Wide Implants (September 13, 2024)
  • K233389 — EK Digital Abutments (May 29, 2024)
  • K222636 — ET Abutment System (April 28, 2023)
  • K191751 — EM Provisional (December 16, 2019)
  • K191201 — EM SA Implant System (November 15, 2019)
  • K183242 — ET IV SA Dental Implants (May 21, 2019)
  • K180527 — IS3 (May 16, 2018)
  • K170421 — ET Hybrid Abutment (January 11, 2018)

Other clearances for product code DZE

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  • 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)