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Smart Sil
EUDAMEDClass I (EU MDR)
Ref SmartSil PuttyRef SmartSil Heavy Body
by Seil Global
Identity
- Trade Name
- Smart Sil EUDAMED
- Device Name
- Dental Impression Material EUDAMED
- Model / Reference
- SmartSil Putty EUDAMEDSmartSil Heavy Body EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800156400059 EUDAMED08800156401612 EUDAMED
- Basic UDI-DI
- 88001564SEIL03J7 EUDAMED
- EMDN Code
- Q01020102 DENTAL IMPRESSION VINYLSILOXANS EUDAMED
Classification
- Device Class
- Class I 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: Silicone dental impression material
Smart Sil by Seil Global — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Silicone dental impression material.
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- Polysil Multipurpose Regular Set — Scican GmbH · Class II
- PERFECTO — CROWN DELTA CORP. · Class II
- Bona-Bite 50ml x 32 — DMP Dental Industry S.A. · Class I
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 | 88001564SEIL03J7 | Class I | Active |
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Manufacturer
- Manufacturer
- Seil Global
- EUDAMED SRN
- KR-MF-000013925
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED 0cab1efe-ca4d-44cd-9701-1e3499519623 61 fields · synced Jul 10, 2026
- EUDAMED 1629ae57-7661-4122-8cd6-2aac0db42f19 61 fields · synced Jul 10, 2026