Identity
- Trade Name
- NightGuard Flex EUDAMEDFDA UDI
- Generic Name
- Dental appliance fabrication material, resin FDA UDI
- Device Name
- NightGuard Flex EUDAMEDIndicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and repositioners. 3D scanned image of a patient's teeh FDA UDI
- Model / Reference
- SRI-0202015 EUDAMEDFDA UDI
- Description
- Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and repositioners. 3D scanned image of a patient's teeh FDA UDI
Identifiers
- Catalog Number
- SRI-0202015 FDA UDI
- Primary DI / UDI-DI
- 00850039704062 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850039704SRI-0202015GW EUDAMED
- Direct Marketing DI
- 00850039704062 EUDAMED
- 510(k) Number
- K212448 FDA UDI
- FDA Product Code
- KMY FDA UDIMQC 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
- 872.5525 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 1 Liter FDA UDI
NightGuard Flex by Sprintray, Inc. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K212448 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 0850039704SRI-0202015GW | Class I | Active |
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Manufacturer
- Manufacturer
- Sprintray Inc.
- EUDAMED SRN
- US-MF-000036081
- Authorised Representative
- SprintRay Europe GmbH DE-AR-000033436
Sources (3)
- EUDAMED 3e55d439-b69b-4365-93b3-4e70c53c59cc 61 fields · synced Jul 28, 2026
- FDA UDI 687dbe7a-e4fb-4e63-93ad-c33349b0dd2a 38 fields · synced May 30, 2026
- FDA 510(k) K212448 1 fields · synced May 18, 2026