Home / 510(k) Clearances / K153332

510(k) K153332

ETIII SA Fixture System (O3.2mm) by Hiossen, Inc. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 2016
Date Received
November 19, 2015
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)
  • K203360 — EK Implants and Abutments System (January 7, 2022)
  • 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)

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)