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Deltasplint
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1370010Model Dental Bite Splint Material
Identity
- Trade Name
- DELTASPLINT EUDAMEDFDA UDI
- Generic Name
- Removable dental occlusal splint, custom-made FDA UDI
- Device Name
- DELTASPLINT, 12 Rods FDA UDI
- Model / Reference
- Dental Bite Splint Material EUDAMED1370010 EUDAMEDFDA UDI
- Description
- DELTASPLINT, 12 Rods FDA UDI
Identifiers
- Catalog Number
- 1370010 FDA UDI
- Primary DI / UDI-DI
- +EDEL13700101 EUDAMEDEDEL13700101 FDA UDI
- Basic UDI-DI
- ++EDELTD10BUDI010011DU EUDAMED
- Unit of Use DI
- +EDEL13700100 EUDAMED
- FDA Product Code
- MQC FDA UDI
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Removable dental occlusal splint, custom-made FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDU FDA UDI
- Market of Registration
- Spain 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
Deltasplint by DeltaMed GmbH — Class IIa — 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 | ++EDELTD10BUDI010011DU | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Deltamed GmbH
- EUDAMED SRN
- DE-MF-000007882
Sources (2)
- EUDAMED 372815e4-7aa4-40a6-b17f-5ad2b603d597 61 fields · synced Jun 17, 2026
- FDA UDI 793076ec-0f36-46ad-a7be-851c78c1a968 35 fields · synced May 30, 2026