Home / 510(k) Clearances / K171185

510(k) K171185

IR Type Implant System by Biotem Co., Ltd. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 2017
Date Received
April 24, 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 Biotem Co., Ltd.

  • K222142 — BR SLA Type Implant System (June 24, 2023)
  • K222144 — IR SLA Type Implant System (June 14, 2023)
  • K190641 — AR_N SLA Type Implant System (February 21, 2020)
  • K171179 — BR Type Implant System (February 9, 2018)
  • K171297 — AR_N Type Implant System (January 31, 2018)

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)