Identity
- Trade Name
- SprintRay NightGuard Firm FDA UDI
- Generic Name
- Dental appliance fabrication material, resin FDA UDI
- Device Name
- The material is an alternative to traditional dental prostheses material. SprintRay NightGuard Firm resin is intended exclusively for professional dental work. FDA UDI
- Model / Reference
- SRI-0202016 FDA UDI
- Description
- The material is an alternative to traditional dental prostheses material. SprintRay NightGuard Firm resin is intended exclusively for professional dental work. FDA UDI
Identifiers
- Catalog Number
- SRI-0202016 FDA UDI
- Primary DI / UDI-DI
- 00850039704161 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
Yes
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
- Total Volume — 1 Liter FDA UDI
Category: Dental appliance fabrication material, resin
SprintRay NightGuard Firm 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 f45e75cb-96b2-429c-910c-847c39ff5b9a 37 fields · synced May 30, 2026