EKX · Handpiece, Direct Drive, Ac-Powered

Device class

Class I

Regulation 872.4200

Total clearances

2020-06-30 → 2025-10-16

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
Perimetrics, Inc.	2	1	2025-09-18
Guilin Woodpecker Medical Instrument Co., Ltd.	2	0	2021-12-17
Advanced Technology Research (A.T.R.) S.R.L.	1	0	2025-08-22
Changzhou Bomedent Medical Technology Co.,Ltd	1	0	2020-06-30
Dentis Co., Ltd.	1	0	2025-03-21
Foshan Cicada Dental Instrument Co, Ltd.	1	0	2021-03-12
Handpiece Headquarters	1	0	2024-12-20
Micro-Nx Co., Ltd.	1	0	2023-11-09
W&H Dentalwerk Buermoos GmbH	1	0	2021-02-24
Meta Systems Co., Ltd.	1	0	2022-09-21
SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.	1	1	2025-10-16
Forum Engineering Technologies (96) , Ltd.	1	0	2024-07-09
Shenzhen Rogin Medical Co., Ltd.	1	0	2025-04-24
Genoss Co., Ltd.	1	0	2024-08-09
Saeyang Microtech Co., Ltd.	1	0	2022-09-19
Dentsply Sirona, Inc.	1	0	2024-07-24
Shenzhen Perfect Medical Instruments Co., Ltd.	1	0	2023-04-26
Changzhou Sifary Medical Technology Co., Ltd.	1	0	2021-01-29
Foshan Coxo Medical Instrument Co., Ltd.	1	0	2023-05-18
Saeshin Precision Co., Ltd.	1	0	2022-06-24

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
D6070	CPT	—	High	Dental handpiece purchase/supply; direct-drive AC handpiece is standard operative equipment

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2025-10-16	K252223	SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.	Alpha Endo Handpiece (Alpha Endo)
2025-09-18	K251597	Perimetrics, Inc.	InnerView System
2025-08-22	K243692	Advanced Technology Research (A.T.R.) S.R.L.	EnDrive (EnDriveUS)
2025-04-24	K242514	Shenzhen Rogin Medical Co., Ltd.	Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)
2025-03-21	K241065	Dentis Co., Ltd.	ChecQ (AC100)
2024-12-20	K243911	Handpiece Headquarters	HPR Cordless Hygiene Handpiece
2024-08-09	K222688	Genoss Co., Ltd.	The Trust
2024-07-24	K233865	Dentsply Sirona, Inc.	X-Smart Pro; X-Smart Pro+
2024-07-09	K232551	Forum Engineering Technologies (96) , Ltd.	EM-07 Cordless Endo Motor
2023-11-09	K232810	Micro-Nx Co., Ltd.	Dental Handpiece, Wireless Endodontic Handpiece, endoit
2023-09-01	K232657	Perimetrics, Inc.	InnerView LC
2023-05-18	K220829	Foshan Coxo Medical Instrument Co., Ltd.	Endo Motor
2023-04-26	K222548	Shenzhen Perfect Medical Instruments Co., Ltd.	Endo Motor
2022-09-21	K210475	Meta Systems Co., Ltd.	EQ-M
2022-09-19	K213897	Saeyang Microtech Co., Ltd.	Pro M Class
2022-06-24	K212043	Saeshin Precision Co., Ltd.	TRAUS ENDO
2021-12-17	K211531	Guilin Woodpecker Medical Instrument Co., Ltd.	Cordless Prophy System, Model: i-Polish
2021-05-10	K203320	Guilin Woodpecker Medical Instrument Co., Ltd.	Endo Motor
2021-03-12	K192649	Foshan Cicada Dental Instrument Co, Ltd.	Endo Motor
2021-02-24	K201703	W&H Dentalwerk Buermoos GmbH	PROXEO Twist Cordless Polishing System PL-40 H
2021-01-29	K201993	Changzhou Sifary Medical Technology Co., Ltd.	E-connect S Endo Motor with built-in Apex Locator
2020-06-30	K191276	Changzhou Bomedent Medical Technology Co.,Ltd	Dental Electrical Motor iRoot Pro