FDA Registration
Active
🇺🇸 United States
SPRINTRAY INC.
Reg #: 3024749697
·
FEI: 3024749697
·
Expires 2026
Products
11
Proprietary Names
26
Establishment Types
2
Classifications
11
Registration Details
- Registration Name
- SPRINTRAY INC.
- Registration Number
- 3024749697
- FEI Number
- 3024749697
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 17601 Sampson Ln.
- City
- Huntington Beach
- State
- CA
- ZIP
- 92647
- Country
- US
Regulatory Submissions
- 510(k) Number
- K222623
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 |
|---|---|---|---|---|---|
| Retainer, Screw Expansion, Orthodontic | DYJ | Class 1 | Dental | No | 2024-09-19 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2019-02-01 |
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2022-12-28 |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | Class 2 | Dental | No | 2022-12-28 |
| Denture, Plastic, Teeth | ELM | Class 2 | Dental | No | 2022-12-28 |
| Mouthguard, Prescription | MQC | Class U | Unknown | No | 2021-11-15 |
| Positioner, Tooth, Preformed | KMY | Class 1 | Dental | No | 2021-11-15 |
| Additively Manufactured, Preformed, Resin Denture Tooth | PZY | Class 2 | Dental | No | 2021-08-24 |
| Crown And Bridge, Temporary, Resin | EBG | Class 2 | Dental | No | 2024-12-02 |
| Indirect Bonding Tray | QJJ | Class 1 | Dental | No | 2021-03-18 |
| Material, Impression Tray, Resin | EBH | Class 1 | Dental | No | 2019-02-01 |
Proprietary Names
Retainer
Precision Guide
Surgical Guide 3
Ceramic Crown (Bleach, A1, A2, A3, B1, B3, C2, D2, D3)
SprintRay Crown (Bleach, A1, A2, A3, B1, B3, C2, D2, D3)
NightGuard Flex
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)
OnX Tough (Hollywood Bleach)
OnX Tough 2 (Bleach, A1, A2, B1, Hollywood White)
Crown HT (A1, A2, A3, B1, Unpigmented, Bleach)
Midas Restore (A1, A2, A3, B1, Bleach, Unpigmented, C2)
Digital Temp (A1, A2, B1, Bleach)
NightGuard Firm
NightGuard Flex 2 (Simply Clear, Ocean Blue)
NightGuard Firm 2 (Midnight Purple)
Standard Denture Base (Light Pink, Original Pink, Dark Pink, Light Meharry, Original Meharry, Dark Meharry)
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)
Apex Flex - Standard Pink
Apex Flex - Light Pink
IDB 2
IDB 3
Try-In 2
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device