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510(k) K243921

LED Curing Lights (DB686 HALO) by Foshan Coxo Medical Instrument Co., Ltd. — Product Code EBZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 2025
Date Received
December 20, 2024
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.

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Other clearances for product code EBZ

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  • K242386 — Bluemoon (May 5, 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)
  • K221152 — CuringPen Dental Curing Light (November 23, 2022)