Identity
- Trade Name
- SprintRay Nightguard Flex 2 - Simply Clear - 1 Kg FDA UDI
- Generic Name
- Dental appliance fabrication material, resin FDA UDI
- Device Name
- SprintRay NightGuard Flex 2 is indicated for the fabrication of dental appliances such as mouthguards and nightguards. FDA UDI
- Model / Reference
- SRI-0202145 FDA UDI
- Description
- SprintRay NightGuard Flex 2 is indicated for the fabrication of dental appliances such as mouthguards and nightguards. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850039704628 FDA UDI
- FDA Product Code
- KMY FDA UDI
- GMDN Term
- Dental appliance fabrication material, resin FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.5525 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Weight — 1 Kilogram FDA UDI
Category: Dental appliance fabrication material, resin
SprintRay Nightguard Flex 2 - Simply Clear - 1 Kg by Sprintray, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Sprintray, Inc.
Sources (1)
- FDA UDI 78724dd3-1331-4f95-a04a-648f5514baa5 36 fields · synced May 30, 2026