FDA Registration
Active
🇺🇸 United States
SPRINTRAY INC.
Reg #: 3014289665
·
FEI: 3014289665
·
Expires 2026
Products
11
Proprietary Names
26
Establishment Types
1
Classifications
11
Registration Details
- Registration Name
- SPRINTRAY INC.
- Registration Number
- 3014289665
- FEI Number
- 3014289665
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 2710, 2705 Media Center Dr Suite #100A
- City
- Los Angeles
- State
- CA
- ZIP
- 90065
- Country
- US
Regulatory Submissions
- 510(k) Number
- K242559
Owner / Operator
- Firm Name
- SprintRay Inc.
- Operator Number
- 10059580
- Address
- 17601 Sampson Ln.
- City
- Huntington Beach
- State
- CA
- Postal Code
- 92647
- Country
- US
- Correspondent
- Sara Moghtadernejad
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2019-02-01 |
| Additively Manufactured, Preformed, Resin Denture Tooth | PZY | Class 2 | Dental | No | 2021-08-24 |
| Retainer, Screw Expansion, Orthodontic | DYJ | Class 1 | Dental | No | 2024-09-19 |
| Crown And Bridge, Temporary, Resin | EBG | Class 2 | Dental | No | 2024-12-02 |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | Class 2 | Dental | No | 2025-06-25 |
| Mouthguard, Prescription | MQC | Class U | Unknown | No | 2021-11-15 |
| Positioner, Tooth, Preformed | KMY | Class 1 | Dental | No | 2021-11-15 |
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2022-12-28 |
| Denture, Plastic, Teeth | ELM | Class 2 | Dental | No | 2022-12-28 |
| Material, Impression Tray, Resin | EBH | Class 1 | Dental | No | 2019-02-01 |
| Indirect Bonding Tray | QJJ | Class 1 | Dental | No | 2021-03-18 |
Proprietary Names
Precision Guide
Surgical Guide 3
Standard Denture Teeth (A1, A2, A3, B1)
NanoCeramic Hybrid OnX (Bleach, A1, B1)
Apex Teeth (A1, A2, B1, Bleach)
High Impact Denture Teeth (Bleach, A1, A2, A3, B1)
Retainer
Digital Temp (A1, A2, B1, Bleach)
Apex Flex - Standard Pink
Apex Flex - Light Pink
NightGuard Flex
Apex Base (Light Pink, Original Pink, Dark Reddish Pink, Opaque Original Pink)
High Impact Denture Base (Light Pink, Original Pink, Dark Pink, Light Meharry, Original Meharry, Bubblegum)
Ceramic Crown (Bleach, A1, A2, A3, B1, B3, C2, D2, D3)
SprintRay Crown (Bleach, A1, A2, A3, B1, B3, C2, D2, D3)
Standard Denture Base (Light Pink, Original Pink, Dark Pink, Light Meharry, Original Meharry, Dark Meharry)
Midas Restore (A1, A2, A3, B1, Bleach, Unpigmented, C2)
Try-In 2
Crown HT (A1, A2, A3, B1, Unpigmented, Bleach)
NightGuard Firm
NightGuard Flex 2 (Simply Clear, Ocean Blue)
NightGuard Firm 2 (Midnight Purple)
IDB 2
IDB 3
OnX Tough (Hollywood Bleach)
OnX Tough 2 (Bleach, A1, A2, B1, Hollywood White)
Establishment Types
Manufacture Medical Device