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Ads Dental System Inc.: FDA-registered device maker in Ontario, CA, United States, 11 510(k) clearances

Name: Ads Dental System Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Ads Dental System Inc. is registered with the FDA (registration 3015376465) in Ontario, CA, United States. It lists 20 device types. The FDA files 11 510(k) clearances under its listings, the newest dated March 12, 2026. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3015376465
Address: 1590 S Milliken Ave., unit A, Ontario, CA 91761, Ontario, CA, United States, 91761
Owner or operator: ADS DENTAL SYSTEM INC. (10062239)
Roles: Remanufacturer, Repackager or relabeler
First device listed: March 8, 2020
Registered through: 2027
Brand names listed: AJEM1; AJEM2; AJEM3, AP-H; AP-H Plus, Beyond 300 Continental, Beyond 400 Continental, Cassette Autoclave(Model:ACA5), Classic 100,Classic 101,Classic 200,Classic 201,Beyond 300,Beyond 301,Beyond 400,Beyond 401, Contra-angle handpiece: WJ-45L, WJ-45TL;Dental Electric Motor:MT2,M2 Pro, D8 LED, DPEX V and more

Devices it lists

Device	Product code	Class	Role	Source
Chair, Dental, Without Operative Unit	NRU	1	Repackager or relabeler	accessdata.fda.gov
Cleaner, Ultrasonic, Medical Instrument	FLG	1	Repackager or relabeler	accessdata.fda.gov
Controller, Foot, Handpiece And Cord	EBW	1	Repackager or relabeler	accessdata.fda.gov
Handpiece, Air-Powered, Dental	EFB	1	Repackager or relabeler	accessdata.fda.gov
Handpiece, Contra- And Right-Angle Attachment, Dental	EGS	1	Repackager or relabeler	accessdata.fda.gov
Handpiece, Direct Drive, Ac-Powered	EKX	1	Repackager or relabeler	accessdata.fda.gov
Lamp, Operating-Room	FQP	2	Repackager or relabeler	accessdata.fda.gov
Light, Operating, Dental	EAZ	1	Repackager or relabeler	accessdata.fda.gov
Locator, Root Apex	LQY	U	Repackager or relabeler	accessdata.fda.gov
Motor, Surgical Instrument, Ac-Powered	GEY	1	Repackager or relabeler	accessdata.fda.gov
Purifier, Air, Ultraviolet, Medical	FRA	2	Repackager or relabeler	accessdata.fda.gov
Scaler, Ultrasonic	ELC	2	Repackager or relabeler	accessdata.fda.gov
Sterilizer, Steam	FLE	2	Repackager or relabeler	accessdata.fda.gov
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	NOF	2	Repackager or relabeler	accessdata.fda.gov
System, X-Ray, Extraoral Source, Digital	MUH	2	Repackager or relabeler	accessdata.fda.gov
Table, Operating-Room, Electrical	GDC	1	Repackager or relabeler	accessdata.fda.gov
Unit, Operative Dental	EIA	1	Repackager or relabeler	accessdata.fda.gov
Unit, Operative Dental, Accessories	NRD	1	Repackager or relabeler	accessdata.fda.gov
Unit, Suction Operatory	EBR	1	Repackager or relabeler	accessdata.fda.gov
Unit, X-Ray, Extraoral With Timer	EHD	2	Remanufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 12, 2026	K252110	Dental X-RAY Unit (AJX200)	EHD	Substantially Equivalent	Guangzhou Ajax Medical Equipment Co., Ltd.	accessdata.fda.gov
August 14, 2025	K250164	Cassette Autoclave (ACA5)	FLE	Substantially Equivalent	Guangzhou Ajax Medical Equipment Co., Ltd.	accessdata.fda.gov
November 21, 2022	K211358	Implanter incl. Accessories	EBW	Substantially Equivalent	Guilin Woodpecker Medical Instrument Co., Ltd.	accessdata.fda.gov
September 28, 2022	K221548	Dental Air Polishing Handpiece	EFB	Substantially Equivalent	Guilin Woodpecker Medical Instrument Co., Ltd.	accessdata.fda.gov
January 13, 2022	K203706	Dental Electric Motor	EBW	Substantially Equivalent	Guilin Woodpecker Medical Instrument Co., Ltd.	accessdata.fda.gov
June 11, 2021	K202766	EOS Air Cleaner	FRA	Substantially Equivalent	Guangzhou Ajax Medical Equipment Co., Ltd.	accessdata.fda.gov
May 10, 2021	K203320	Endo Motor	EKX	Substantially Equivalent	Guilin Woodpecker Medical Instrument Co., Ltd.	accessdata.fda.gov
April 23, 2021	K210312	PlutoX Digital Intraoral X-Ray Imaging System	MUH	Substantially Equivalent	Iray Technology Taicang , Ltd.	accessdata.fda.gov
December 18, 2018	K181087	Apex Locator, DPEX III	LQY	Substantially Equivalent	Guilin Woodpecker Medical Instrument Co., Ltd.	accessdata.fda.gov
September 5, 2014	K132245	AJAX DENTAL UNIT	EIA	Substantially Equivalent	Pro Dental Services, LLC	accessdata.fda.gov
August 21, 2006	K053555	ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-L	ELC	Substantially Equivalent	Guilin Woodpecker Medical Instrument Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated March 12, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.