EBZ · Activator, Ultraviolet, For Polymerization

Device class

Class II

Regulation 872.6070

Total clearances

2020-01-09 → 2026-06-18

Last 12 months

Unique sponsors

Classification details

Medical specialty

Dental

Review panel

Regulation number

872.6070

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Garrison Dental Solutions, LLC	2	0	2024-08-01
Ultradent Products, Inc.	2	0	2022-02-22
Foshan Coxo Medical Instrument Co., Ltd.	2	0	2025-04-11
Dent4you AG	1	0	2022-12-22
Genoss Co., Ltd.	1	0	2025-05-05
Handpiece Headquarters	1	0	2023-11-02
Foshan Cicada Dental Instrument Co, Ltd.	1	0	2020-02-13
Changzhou Sifary Medical Technology Co., Ltd.	1	0	2022-11-23
Meta Systems Co., Ltd.	1	1	2025-10-14
Dxm Co., Ltd.	1	0	2020-01-10
Dentmate Technology Co. , Ltd.	1	0	2022-09-16
DiaDent Group International	1	0	2020-08-07
Guangzhou Rebornendo Medical Instrument Co., Ltd.	1	1	2026-06-18
Guilin Refine Medical Instrument Co., Ltd.	1	0	2023-11-15
Good Doctors Co., Ltd.	1	0	2023-08-04
Ezgo Group, Inc.	1	0	2020-01-09
Premium Plus (Dongguan) Limited	1	0	2025-04-10

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
D9000	HCPCS	—	Low	UV polymerization activator is equipment/supply, typically included in restorative procedure costs

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-06-18	K253131	Guangzhou Rebornendo Medical Instrument Co., Ltd.	Curing Light (M-Cure 6)
2025-10-14	K253461	Meta Systems Co., Ltd.	Demi Pro
2025-05-05	K242386	Genoss Co., Ltd.	Bluemoon
2025-04-11	K243921	Foshan Coxo Medical Instrument Co., Ltd.	LED Curing Lights (DB686 HALO)
2025-04-10	K250009	Premium Plus (Dongguan) Limited	LED Curing Light (C01-X, C02-X)
2024-08-01	K241238	Garrison Dental Solutions, LLC	LOOP LED Curing Light System (CLK01)
2023-11-15	K223414	Guilin Refine Medical Instrument Co., Ltd.	Curing Light, Model: MaxCure 9
2023-11-02	K233518	Handpiece Headquarters	BASE290 LED Curing Light
2023-08-04	K223507	Good Doctors Co., Ltd.	CL-DP40 (Drs Light PRIME), CL-DP40 (Drs Light CHOICE)
2022-12-22	K223142	Dent4you AG	Coltolux Comfort LED Curing Light
2022-12-08	K220826	Foshan Coxo Medical Instrument Co., Ltd.	LED Curing Light
2022-11-23	K221152	Changzhou Sifary Medical Technology Co., Ltd.	CuringPen Dental Curing Light
2022-09-16	K221194	Dentmate Technology Co. , Ltd.	LEDEX
2022-02-22	K220471	Ultradent Products, Inc.	VALO X, VALO X Accessory Lenses
2021-03-01	K210550	Ultradent Products, Inc.	VALO Grand Corded and Accessory Lenses
2020-08-14	K200775	Garrison Dental Solutions, LLC	LOOP LED Curing Light System
2020-08-07	K200809	DiaDent Group International	D-LUX+
2020-02-13	K192233	Foshan Cicada Dental Instrument Co, Ltd.	LED Curing Light
2020-01-10	K191221	Dxm Co., Ltd.	Cybird LED Curing Light
2020-01-09	K192009	Ezgo Group, Inc.	LED Curing Light