FDA Registration
Active
🇺🇸 United States
NUCARE LLC
Reg #: 3042367543
·
FEI: 3042367543
·
Expires 2026
Products
23
Proprietary Names
9
Establishment Types
2
Classifications
23
Registration Details
- Registration Name
- NUCARE LLC
- Registration Number
- 3042367543
- FEI Number
- 3042367543
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 10680 Silicon Ave Unit A (Unit 20
- City
- Montclair
- State
- CA
- ZIP
- 91763
- Country
- US
Regulatory Submissions
- 510(k) Number
- K190484
Owner / Operator
- Firm Name
- NuCare LLC
- Operator Number
- 10094265
- Address
- 848 Stewart Dr Ste 101
- City
- Sunnyvale
- State
- CA
- Postal Code
- 94085
- Country
- US
- Correspondent
- Oscar Fu
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 2025-11-29 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2025-11-29 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2026-04-29 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2025-11-29 |
| Material, Impression Tray, Resin | EBH | Class 1 | Dental | No | 2025-11-29 |
| Finger Cot | LZB | Class 1 | General Hospital | No | 2026-06-11 |
| Unit, Operative Dental, Accessories | NRD | Class 1 | Dental | No | 2025-12-01 |
| Absorber, Saliva, Paper | KHR | Class 1 | Dental | No | 2025-11-29 |
| Mouthpiece, Saliva Ejector | DYN | Class 1 | Dental | No | 2025-11-29 |
| Dental Barriers And Sleeves | PEM | Class 2 | General, Plastic Surgery | No | 2025-11-29 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2025-11-29 |
| Gown, Examination | FME | Class 1 | General Hospital | No | 2025-11-29 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2025-11-29 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2025-11-29 |
| Retractor, All Types | EIG | Class 1 | Dental | No | 2026-04-29 |
| Chair, Dental, Without Operative Unit | NRU | Class 1 | Dental | No | 2025-11-29 |
| Cotton, Roll | EFN | Class 1 | Dental | No | 2025-11-29 |
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2025-11-29 |
| Accessories, Retractor, Dental | EIF | Class 1 | Dental | No | 2026-05-01 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2025-12-01 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2025-12-01 |
| Unit, Syringe, Air And/Or Water | ECB | Class 1 | Dental | No | 2025-11-29 |
| Wrap, Sterilization | FRG | Class 2 | General Hospital | No | 2025-11-29 |
Proprietary Names
NuCare
NuCare intraoral occlusal mirror
Hand and Arm Protection Sleeve
FINGER COT
NuCare Dental Retractor
retractor self spanning child plastic w/holder
retractor self spanning adult 50mm plastic blue
retractor self spanning adult plastic w/holder
retractor self spanning
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198