Home / 510(k) Clearances / K191221

510(k) K191221

Cybird LED Curing Light by Dxm Co., Ltd. — Product Code EBZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 2020
Date Received
May 7, 2019
Clearance Type
Special
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 Dxm Co., Ltd.

  • K173876 — Cybird LED Curing Light (January 24, 2018)
  • K121093 — D1 LED CURING LIGHT, SPEC 3, DENTRONIX LED 3000 (November 27, 2012)
  • K081694 — DENJECTOR (September 12, 2008)
  • K042703 — CYBIRD LED CURING LIGHT (October 12, 2004)
  • K040116 — HAWK INTRAORAL CAMERA AND ACCESSORIES (April 20, 2004)

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)
  • K220826 — LED Curing Light (December 8, 2022)