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Deltabond
EUDAMEDFDA UDIClass I (EU MDR)
Ref 1370020Model Dental Bite Splint Material
Identity
- Trade Name
- DELTABOND EUDAMEDFDA UDI
- Generic Name
- Dental prosthesis priming agent FDA UDI
- Device Name
- DELTABOND, Bottle 10ml FDA UDI
- Model / Reference
- Dental Bite Splint Material EUDAMED1370020 EUDAMEDFDA UDI
- Description
- DELTABOND, Bottle 10ml FDA UDI
Identifiers
- Catalog Number
- 1370020 FDA UDI
- Primary DI / UDI-DI
- +EDEL13700200 EUDAMEDEDEL13700200 FDA UDI
- Basic UDI-DI
- ++EDELTD10BUDI020012E9 EUDAMED
- Direct Marketing DI
- +EDEL13700200 EUDAMED
- FDA Product Code
- MQC FDA UDI
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Dental prosthesis priming agent FDA UDI
Classification
- Device Class
- Class I 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
Deltabond by DeltaMed GmbH — 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
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++EDELTD10BUDI020012E9 | Class I | Active |
| EUDAMED | European Union | CE/MDR | ++EDELTD10BUDI020012E9 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Deltamed GmbH
- EUDAMED SRN
- DE-MF-000007882
Sources (2)
- EUDAMED 0710e92d-0b5a-43cb-8a01-4645a8e062d7 61 fields · synced Jun 8, 2026
- FDA UDI 438b9afb-0fae-455f-94e9-c9d95d1b06a5 35 fields · synced May 30, 2026