Home / 510(k) Clearances / K210220

510(k) K210220

Kontact Dental Implant System by Biotech Dental, Sas — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2021
Date Received
January 27, 2021
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 Biotech Dental, Sas

  • K242261 — Accelx Implant System (November 6, 2024)
  • K213997 — Kontact Dental Implant System (July 15, 2022)
  • K212068 — Biotech Dental Kits (November 8, 2021)

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)