Home / 510(k) Clearances / K090049

510(k) K090049

ATLAS IMPLANT SYSTEM- MINI PLUS by Cowellmedi Co., Ltd. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 2009
Date Received
January 7, 2009
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 Cowellmedi Co., Ltd.

  • K242287 — SFIT Abutment (September 16, 2025)
  • K241127 — INNO SLA Mini Plus® Implant System (December 27, 2024)
  • K231411 — INNO SLA Submerged Hybrid Ti-Base System (December 20, 2023)
  • K232546 — Meta G UCLA Abutment (November 21, 2023)
  • K231395 — INNO SLA Submerged Narrow Implant System (October 18, 2023)
  • K211554 — InnoGenic Non-resorbable Membrane (February 24, 2023)
  • K201323 — INNO SLA Submerged Implant System (January 25, 2022)
  • K132242 — INNO SLA SUBMERGED IMPLANT SYSTEM (December 6, 2013)
  • K100850 — COWELL IMPLANT SYSTEM (December 20, 2010)
  • K090054 — ATLAS IMPLANT SYSTEM - WIDE PLUS (July 29, 2009)

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)