EBW · Controller, Foot, Handpiece And Cord

Device class

Class I

Regulation 872.4200

Total clearances

2020-09-04 → 2026-01-30

Last 12 months

Unique sponsors

Classification details

Medical specialty

Dental

Review panel

Regulation number

872.4200

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
Micro-Nx Co., Ltd.	3	0	2025-07-18
Nakanishi, Inc.	2	0	2024-06-24
Saeshin Precision Co., Ltd.	2	1	2026-01-30
Guilin Woodpecker Medical Instrument Co., Ltd.	2	0	2022-11-21
Cefla S.C.	2	0	2024-04-01
Dentsply Sirona, Inc.	1	0	2025-08-25
Foshan Coxo Medical Instrument Co., Ltd.	1	0	2022-09-27
Dentium Co., Ltd.	1	0	2020-09-04
Guilin Aesthedent Medical Instruments Co., Ltd.	1	0	2025-04-11
Dentalez, Inc., Stardental Division	1	1	2026-01-12
Codent Technical Industry Co., Ltd.	1	0	2024-03-11
Foshan Cicada Dental Instrument Co, Ltd.	1	0	2022-03-11

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	Dental handpiece controller is equipment cost, typically included in practice overhead

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-01-30	K251407	Saeshin Precision Co., Ltd.	Motor Handpiece and Control Unit (SDI10)
2026-01-12	K251701	Dentalez, Inc., Stardental Division	Star E900 Electric System
2025-08-25	K251811	Dentsply Sirona, Inc.	Motor and Apex Module (MaAM)
2025-07-18	K231562	Micro-Nx Co., Ltd.	ELEC ENGINE (Model: ISE-170L)
2025-04-11	K242646	Guilin Aesthedent Medical Instruments Co., Ltd.	Dental Implant Unit
2024-06-24	K233288	Nakanishi, Inc.	NLZ Built-In Motor System
2024-06-20	K233117	Nakanishi, Inc.	Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)
2024-04-01	K230895	Cefla S.C.	CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3, i-XR3 L, i-XR3 L FLUO, i-XS4,
2024-03-11	K231864	Codent Technical Industry Co., Ltd.	Fiber Optic Brushless Electronic Micromotor, model: iM100
2022-11-21	K211358	Guilin Woodpecker Medical Instrument Co., Ltd.	Implanter incl. Accessories
2022-09-27	K220831	Foshan Coxo Medical Instrument Co., Ltd.	Dental Implantation Systems, Dental Electrical Motors
2022-05-09	K213022	Cefla S.C.	CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED
2022-03-11	K202075	Foshan Cicada Dental Instrument Co, Ltd.	Dental Electric Motor
2022-02-07	K201191	Micro-Nx Co., Ltd.	ELEC-LED
2022-01-13	K203706	Guilin Woodpecker Medical Instrument Co., Ltd.	Dental Electric Motor
2021-05-21	K201192	Micro-Nx Co., Ltd.	Impla-NX (Model: ISE-270M)
2021-02-11	K201292	Saeshin Precision Co., Ltd.	TRAUS SIP20
2020-09-04	K193341	Dentium Co., Ltd.	iCTmotor (WL-1)