FDA Registration
Active
🇺🇸 United States
ADS DENTAL SYSTEM INC.
Reg #: 3015376465
·
FEI: 3015376465
·
Expires 2026
Products
14
Proprietary Names
25
Establishment Types
2
Classifications
14
Registration Details
- Registration Name
- ADS DENTAL SYSTEM INC.
- Registration Number
- 3015376465
- FEI Number
- 3015376465
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 1590 S Milliken Ave., unit A, Ontario, CA 91761
- City
- Ontario
- State
- CA
- ZIP
- 91761
- Country
- US
Regulatory Submissions
- 510(k) Number
- K210312
Owner / Operator
- Firm Name
- ADS DENTAL SYSTEM INC.
- Operator Number
- 10062239
- Address
- 1590 S Milliken Ave., unit A, Ontario, CA 91761
- City
- Ontario
- State
- CA
- Postal Code
- 91761
- Country
- US
- Correspondent
- QINGYUN HE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, X-Ray, Extraoral Source, Digital | MUH | Class 2 | Dental | No | 2025-02-22 |
| Motor, Surgical Instrument, Ac-Powered | GEY | Class 1 | General, Plastic Surgery | No | 2025-07-29 |
| Table, Operating-Room, Electrical | GDC | Class 1 | General, Plastic Surgery | No | 2024-01-22 |
| Chair, Dental, Without Operative Unit | NRU | Class 1 | Dental | No | 2020-03-08 |
| Sterilizer, Steam | FLE | Class 2 | General Hospital | No | 2025-08-20 |
| Purifier, Air, Ultraviolet, Medical | FRA | Class 2 | General Hospital | No | 2023-09-27 |
| Unit, Suction Operatory | EBR | Class 1 | Dental | No | 2020-04-16 |
| Lamp, Operating-Room | FQP | Class 2 | General, Plastic Surgery | No | 2020-03-08 |
| Unit, Operative Dental | EIA | Class 1 | Dental | No | 2020-03-08 |
| Cleaner, Ultrasonic, Medical Instrument | FLG | Class 1 | General Hospital | No | 2025-12-02 |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | Class 2 | Dental | No | 2025-04-22 |
| Unit, Operative Dental, Accessories | NRD | Class 1 | Dental | No | 2020-03-08 |
| Light, Operating, Dental | EAZ | Class 1 | Dental | No | 2020-03-08 |
| Unit, X-Ray, Extraoral With Timer | EHD | Class 2 | Dental | No | 2026-03-16 |
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)
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)
LED Dental Light(model: Amber, Amber II, Pebble, Pebble II, Hubble, Hubble II, Leo, Libra, Whale)
Dental X-RAY Unit(Model:AJX200, AJX100, AJX300, AJX400, AJX500, AJX600, AJX700)
Establishment Types
Repack or Relabel Medical Device
Remanufacture Medical Device