Identity
- Trade Name
- Retainer - Clear EUDAMEDSprintRay Retainer FDA UDI
- Generic Name
- Dental appliance fabrication material, resin FDA UDI
- Device Name
- Retainer - Clear EUDAMEDSprintRay Retainer is an alternative to traditional thermoplastic material used for the fabrication of retainers. It is intended exclusively for professional dental work. FDA UDI
- Model / Reference
- SRI-0202161 EUDAMEDFDA UDI
- Description
- SprintRay Retainer is an alternative to traditional thermoplastic material used for the fabrication of retainers. It is intended exclusively for professional dental work. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850039704918 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850039704SRI-0202161HA EUDAMED
- FDA Product Code
- DYJ FDA UDI
- EMDN Code
- Q0102050199 DENTISTRY RESINS - OTHER EUDAMED
- GMDN Term
- Dental appliance fabrication material, resin FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.5410 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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 — 500 Gram FDA UDI
Retainer - Clear by Sprintray, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0850039704SRI-0202161HA | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sprintray Inc.
- EUDAMED SRN
- US-MF-000036081
- Authorised Representative
- SprintRay Europe GmbH DE-AR-000033436
Sources (2)
- EUDAMED cc86312b-cabb-4999-aed8-3a823cce15ee 61 fields · synced Aug 2, 2026
- FDA UDI cd709080-49ff-4c1d-92ea-e833b46cced8 35 fields · synced May 30, 2026