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EBZ — Activator, Ultraviolet, For Polymerization Class II

FDA Device Classification

Classification Details

Product Code
EBZ
Device Class
Class II
Regulation Number
872.6070
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K253461meta systems coDemi ProOctober 14, 2025
K242386genoss coBluemoonMay 5, 2025
K243921foshan coxo medical instrument coLED Curing Lights (DB686 HALO)April 11, 2025
K250009premium plus (dongguan) limitedLED Curing Light (C01-X, C02-X)April 10, 2025
K241238garrison dental solutionsLOOP™ LED Curing Light System (CLK01)August 1, 2024
K223414guilin refine medical instrument coCuring Light, Model: MaxCure 9November 15, 2023
K233518handpiece headquartersBASE290 LED Curing LightNovember 2, 2023
K223507good doctors coCL-DP40 (Dr’s Light PRIME), CL-DP40 (Dr’s Light CHOICE)August 4, 2023
K223142dent4youColtolux Comfort LED Curing LightDecember 22, 2022
K220826foshan coxo medical instrument coLED Curing LightDecember 8, 2022
K221152changzhou sifary medical technology coCuringPen Dental Curing LightNovember 23, 2022
K221194dentmate technology co.LEDEXSeptember 16, 2022
K220471ultradent productsVALO X, VALO X Accessory LensesFebruary 22, 2022
K210550ultradent productsVALO Grand Corded and Accessory LensesMarch 1, 2021
K200775garrison dental solutionsLOOP LED Curing Light SystemAugust 14, 2020
K200809diadent group internationalD-LUX+August 7, 2020
K192233foshan cicada dental instrument coLED Curing LightFebruary 13, 2020
K191221dxm coCybird LED Curing LightJanuary 10, 2020
K192009ezgo groupLED Curing LightJanuary 9, 2020
K191865dentsply sironaSmartLite Pro Modular LED Curing LightNovember 20, 2019