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Deltaglace
EUDAMEDFDA UDIClass I (EU MDR)
Ref 1370030Model Dental Bite Splint Material
Identity
- Trade Name
- DELTAGLACE EUDAMEDFDA UDI
- Generic Name
- Removable dental occlusal splint, custom-made FDA UDI
- Device Name
- DELTAGLACE, Bottle 10ml FDA UDI
- Model / Reference
- Dental Bite Splint Material EUDAMED1370030 EUDAMEDFDA UDI
- Description
- DELTAGLACE, Bottle 10ml FDA UDI
Identifiers
- Catalog Number
- 1370030 FDA UDI
- Primary DI / UDI-DI
- +EDEL13700300 EUDAMEDEDEL13700300 FDA UDI
- Basic UDI-DI
- ++EDELTD10BUDI020012E9 EUDAMED
- Direct Marketing DI
- +EDEL13700300 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 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
Deltaglace 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
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 daf592b7-a556-4a93-8a83-f10d2b6139c1 61 fields · synced Jun 17, 2026
- FDA UDI 8420fead-3727-47d2-b793-f289426c93cc 35 fields · synced May 30, 2026