Home / 510(k) Clearances / K220826

510(k) K220826

LED Curing Light by Foshan Coxo Medical Instrument Co., Ltd. — Product Code EBZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 2022
Date Received
March 22, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Activator, Ultraviolet, For Polymerization
Device Class
Class II
Regulation Number
872.6070
Review Panel
DE
Submission Type

Other clearances by Foshan Coxo Medical Instrument Co., Ltd.

  • K243921 — LED Curing Lights (DB686 HALO) (April 11, 2025)
  • K220179 — High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Ai (September 22, 2023)
  • K220829 — Endo Motor (May 18, 2023)
  • K222096 — Endo Ultrasonic Activator (March 23, 2023)
  • K220831 — Dental Implantation Systems, Dental Electrical Motors (September 27, 2022)
  • K212178 — Root Apex Locator (July 20, 2022)

Other clearances for product code EBZ

  • K253461 — Demi Pro (October 14, 2025)
  • K242386 — Bluemoon (May 5, 2025)
  • K243921 — LED Curing Lights (DB686 HALO) (April 11, 2025)
  • K250009 — LED Curing Light (C01-X, C02-X) (April 10, 2025)
  • K241238 — LOOP™ LED Curing Light System (CLK01) (August 1, 2024)
  • K223414 — Curing Light, Model: MaxCure 9 (November 15, 2023)
  • K233518 — BASE290 LED Curing Light (November 2, 2023)
  • K223507 — CL-DP40 (Dr’s Light PRIME), CL-DP40 (Dr’s Light CHOICE) (August 4, 2023)
  • K223142 — Coltolux Comfort LED Curing Light (December 22, 2022)
  • K221152 — CuringPen Dental Curing Light (November 23, 2022)