Home / 510(k) Clearances / K173938

510(k) K173938

IS-III HActive Fixture by Neobiotech Co., Ltd. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 2018
Date Received
December 26, 2017
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 Neobiotech Co., Ltd.

  • K232528 — Protective Cap (April 30, 2024)
  • K232049 — IS-III active Short Implant (March 28, 2024)
  • K210903 — IS Multi Unit Abutment System (July 23, 2021)
  • K190849 — IS-III active System_S-narrow Type (August 14, 2019)
  • K181137 — IT-III active System (November 16, 2018)
  • K181138 — IS-III active System (October 3, 2018)
  • K181178 — S-mini active Fixture (July 24, 2018)
  • K160991 — Neo GBR System (January 10, 2017)
  • K120503 — CMI IMPLANT IS II ACTIVE (June 18, 2012)
  • K113554 — CMI IMPLANT IS SYSTEM (April 5, 2012)

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)