Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015376465

FEI Number

3015376465

Entity Name

ADS DENTAL SYSTEM INC.

City/State/Country

Ontario, CA, US

Establishment Address

1590 S Milliken Ave., unit A, Ontario, CA 91761, Ontario, CA 91761, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

ADS DENTAL SYSTEM INC. (Owner Number: 10062239)

Owner / Operator Contact Address

1590 S Milliken Ave., unit A, Ontario, CA 91761, Ontario, CA 91761, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PlutoX Digital Intraoral X-ray Imaging System AJEM1; AJEM2; AJEM3 Surgical Chair, Operating Table(model:AA6688) Dental Chair Cassette Autoclave(Model:ACA5) EOS Extraoral Suction System(model: Optima 350; EOS; EOS Plus; Thor; Thor-s) Suction System, Dry Vaccum System (model: SP1000,SP3000,SP3000+,SP5000,SP5000+,ADS V3, ADS V5, ADS V7,ADS V10, ADS V14) Suction System, Dry Vaccum System (model: SV300,SV400,SV600,SV800,SV1000,PV100,V20,V40,V60,V80,V100) Suction System, Dry Vaccum System (model: V600,DV800,DV1000,DV1500) LED Surgical Light Dental unit (Model:AJ10; AJ11; AJ12; AJ15; AJ16; AJ17;AJ18,AJ19;AJ22;AJ25;AJ26;AJ28,AJ21,AJ27) Mobile Cart Self Contained Enlarged Orthodontic Mobile Cart OC-2 Beyond 300 Continental, Beyond 400 Continental Portable Delivery System Classic 100,Classic 101,Classic 200,Classic 201,Beyond 300,Beyond 301,Beyond 400,Beyond 401 ultima 800, ultima 801 Ultrasonic Cleaner (Model:AUC3.5, AUC4, AUC6, AUC15, AUC22) Intraoral Scanner(Model: AJS1) Oil free air compressor(Model:BA100;BA200;BA220;BA300;BA400;BA600;BA1000;BA1200;AT200;AT260;AT300;AT400;AT600;AT1000) Suction System, Dry Vaccum System (model: SP1000,SP3000,SP3000+,SP5000,SP5000+,ADS V3, ADS V5, ADS V7,ADS V10, ADS V14) Oil free air compressor(Model: UA200;UA300;UA400;UA600;UA900;UA1000;UA1200;BA800;AT800;AT20P;AT40P;AT60P;AT80P;AT100P) Suction System, Dry Vaccum System(model: SV300,SV400,SV600,SV800,SV1000,PV100) Oil free air compressor(Model: AJAX100;AJAX200;AJAX300;AJAX400;AJAX600;AJAX800;AJAX1000)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2025-02-22
GEY	Motor, Surgical Instrument, Ac-Powered	General, Plastic Surgery	Class 1	878.4820	2025-07-29
GDC	Table, Operating-Room, Electrical	General, Plastic Surgery	Class 1	878.4960	2024-01-22
NRU	Chair, Dental, Without Operative Unit	Dental	Class 1	872.6250	2020-03-08
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2025-08-20
FRA	Purifier, Air, Ultraviolet, Medical	General Hospital	Class 2	880.6500	2023-09-27
EBR	Unit, Suction Operatory	Dental	Class 1	872.6640	2020-04-16
FQP	Lamp, Operating-Room	General, Plastic Surgery	Class 2	878.4580	2020-03-08
EIA	Unit, Operative Dental	Dental	Class 1	872.6640	2020-03-08
FLG	Cleaner, Ultrasonic, Medical Instrument	General Hospital	Class 1	880.6150	2025-12-02
NOF	System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	Dental	Class 2	872.3661	2025-04-22
NRD	Unit, Operative Dental, Accessories	Dental	Class 1	872.6640	2020-03-08

Official Correspondent

QINGYUN HE

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ADS DENTAL SYSTEM INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K221008	Shanghai Handy Medical Equipment Co., Ltd.	HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)	2022-06-22
K160788	Ray Co., Ltd.	RIOScan (RPS500)	2016-04-15
K905383	Micro Surgical Instruments Corp.	2710-000 OSCILLATING SAW, GENERAL ASSEMBLY	1991-06-18
K913369	Micro Surgical Instruments Corp.	MICRO-AIRE MODEL 2060	1991-11-01
K021223	Sauter AG	BELIMED STEAM STERILIZER, MODEL TOP 5000	2002-06-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2025	Young Dental Manufacturing I, LLC	1	BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015376465. Last updated year: 2026. Please use registration number 3015376465 when referencing this establishment in official correspondence.