FDA Registration
Active
🇺🇸 United States
CSY INTERNATIONAL LLC
Reg #: 3016543896
·
FEI: 3016543896
·
Expires 2026
Products
27
Proprietary Names
15
Establishment Types
1
Classifications
27
Registration Details
- Registration Name
- CSY INTERNATIONAL LLC
- Registration Number
- 3016543896
- FEI Number
- 3016543896
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 6737 Palo Verde Pl
- City
- Rancho Cucamonga
- State
- CA
- ZIP
- 91739
- Country
- US
Regulatory Submissions
- 510(k) Number
- K201410
Owner / Operator
- Firm Name
- CSY INTERNATIONAL LLC
- Operator Number
- 10062340
- Address
- 6737 Palo Verde Pl
- City
- Rancho Cucamonga
- State
- CA
- Postal Code
- 91739
- Country
- US
- Correspondent
- Xiang Yan
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bracket, Ceramic, Orthodontic | NJM | Class 2 | Dental | No | 2021-06-15 |
| Activator, Ultraviolet, For Polymerization | EBZ | Class 2 | Dental | No | 2022-10-20 |
| Retainer, Screw Expansion, Orthodontic | DYJ | Class 1 | Dental | No | 2020-01-14 |
| Setter, Band, Orthodontic | ECR | Class 1 | Dental | No | 2020-01-14 |
| Tube, Orthodontic | DZD | Class 1 | Dental | No | 2020-01-14 |
| Bracket, Metal, Orthodontic | EJF | Class 1 | Dental | No | 2020-01-14 |
| Spring, Orthodontic | ECO | Class 1 | Dental | No | 2020-01-14 |
| Agent, Polishing, Abrasive, Oral Cavity | EJR | Class 1 | Dental | No | 2022-06-28 |
| Implant, Endosseous, Orthodontic | OAT | Class 2 | Dental | No | 2020-11-24 |
| Aligner, Bracket, Orthodontic | ECQ | Class 1 | Dental | No | 2020-01-14 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2022-06-28 |
| Adhesive, Bracket And Tooth Conditioner, Resin | DYH | Class 2 | Dental | No | 2022-10-20 |
| Maintainer, Space Preformed, Orthodontic | DYT | Class 1 | Dental | No | 2020-01-14 |
| Pusher, Band, Orthodontic | ECS | Class 1 | Dental | No | 2020-01-14 |
| Retractor, All Types | EIG | Class 1 | Dental | No | 2022-06-28 |
| Wire, Orthodontic | DZC | Class 1 | Dental | No | 2020-01-14 |
| Band, Elastic, Orthodontic | ECI | Class 1 | Dental | No | 2020-01-14 |
| Driver, Band, Orthodontic | ECT | Class 1 | Dental | No | 2020-01-14 |
| Instrument, Ligature Tucking, Orthodontic | ECP | Class 1 | Dental | No | 2020-01-14 |
| Headgear, Extraoral, Orthodontic | DZB | Class 2 | Dental | No | 2022-10-27 |
| Applicator, Resin | KXR | Class 1 | Dental | No | 2022-10-22 |
| Stripper, Surgical | HRT | Class 1 | Orthopedic | No | 2020-11-24 |
| Band, Material, Orthodontic | DYO | Class 1 | Dental | No | 2020-01-14 |
| Clamp, Wire, Orthodontic | ECN | Class 1 | Dental | No | 2020-01-14 |
| Plier, Orthodontic | JEX | Class 1 | Dental | No | 2020-01-14 |
| Band, Preformed, Orthodontic | ECM | Class 1 | Dental | No | 2020-01-14 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2022-06-28 |
Proprietary Names
J&J ORTHODONTICS
NIEVE
CICADA
J&J Orthodontics
J&J Ortho
Precisa
Veloz
Beacon
Suave
Sigilo
Precisa II
Dorada
Claro
GNI
Caber
Establishment Types
Repack or Relabel Medical Device