Identity
- Trade Name
- EKULF NightGuard EUDAMEDThe Doctor's FDA UDI
- Generic Name
- Custom-made mouthguard FDA UDI
- Device Name
- Dental Guards EUDAMEDTD EKULF NIGHTGUARD 1CT PAD 12 FDA UDI
- Model / Reference
- 7050 EUDAMEDFDA UDI
- Description
- TD EKULF NIGHTGUARD 1CT PAD 12 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07392222170504 EUDAMEDFDA UDI
- Basic UDI-DI
- 506001888DNTKGUARD001RS EUDAMED
- FDA Product Code
- OBR FDA UDI
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
- GMDN Term
- Custom-made mouthguard FDA UDI
Classification
- Device Class
- Class I EUDAMEDU FDA UDI
- Market of Registration
- Sweden 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
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
EKULF NightGuard by DenTek Oral Care Limited — 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 | 506001888DNTKGUARD001RS | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- DenTek Oral Care Limited
- EUDAMED SRN
- GB-MF-000034440
- Authorised Representative
- Elara Pharmaservices Europe Ltd IE-AR-000011852
Sources (2)
- EUDAMED 2b7f8a8a-6d74-4d34-ad8f-2edbab1c6f08 61 fields · synced Jun 20, 2026
- FDA UDI 4d93cb2e-2cd5-408a-9eea-6cc94bb71d28 34 fields · synced May 30, 2026