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Estesil H2TOP EHF Extra High Flowability Gun Mix 1:1 FAST
EUDAMEDClass I (EU MDR)
Ref 44370 Model ESTESIL
Identity
- Trade Name
- Estesil H2TOP EHF Extra High Flowability Gun Mix 1:1 FAST EUDAMED
- Model / Reference
- ESTESIL EUDAMED44370 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D997443701 EUDAMED
- Basic UDI-DI
- ++D997SILICONSM5 EUDAMED
- EMDN Code
- Q01020104 DENTAL IMPRESSION SILICONES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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: Silicone dental impression material
Estesil H2TOP EHF Extra High Flowability Gun Mix 1:1 FAST by Tokuyama Dental Italy S.r.l. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | ++D997SILICONSM5 | Class I | Active |
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Manufacturer
- Manufacturer
- Tokuyama Dental Italy S.r.l.
- EUDAMED SRN
- IT-MF-000009968
Sources (1)
- EUDAMED c252a501-4113-4956-946f-c934954cf22f 61 fields · synced Jun 18, 2026