Identity
- Trade Name
- Lute Glass (A3) EUDAMED
- Device Name
- Glass Ionomer EUDAMED
- Model / Reference
- 8906170050161 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08906170050161 EUDAMED
- Basic UDI-DI
- 890617005B110GI0RW EUDAMED
- EMDN Code
- Q01010106 DENTAL RESTORATION GLASS IONOMERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Glass ionomer dental cement
Lute Glass (A3) by D Tech Dental Technologies — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Glass ionomer dental cement.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 890617005B110GI0RW | Class IIa | Active |
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Manufacturer
- Manufacturer
- D Tech Dental Technologies
- EUDAMED SRN
- IN-MF-000024847
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 320f3b2b-7bd0-4a86-99e2-27d79f7dad39 61 fields · synced Jul 22, 2026