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i-Sil Heavy Body Jumbo
EUDAMEDFDA UDIClass I (EU MDR)
Ref #7307PJURef #7307P02
by Spident
Identity
- Trade Name
- i-Sil Heavy Body Jumbo EUDAMEDi-Sil Heavy Body EUDAMEDI-SiL Jumbo Heavy Body FDA UDI
- Generic Name
- Silicone dental impression material FDA UDI
- Device Name
- i-Sil Heavy Body EUDAMED
- Model / Reference
- #7307PJU EUDAMED#7307P02 EUDAMED102-0602 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809262958034 EUDAMEDFDA UDI08809262955071 EUDAMED
- Basic UDI-DI
- 880926295HBZQ EUDAMED
- Direct Marketing DI
- 08809262958034 EUDAMED08809262955071 EUDAMED
- FDA Product Code
- ELW FDA UDI
- EMDN Code
- Q01020102 DENTAL IMPRESSION VINYLSILOXANS EUDAMED
- GMDN Term
- Silicone dental impression material FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3660 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
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
Yes
FDA UDI
Category: Silicone dental impression material
i-Sil Heavy Body Jumbo by Spident — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
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 (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 | 880926295HBZQ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Spident
- EUDAMED SRN
- KR-MF-000008691
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (3)
- EUDAMED d82c507c-c166-4421-aacc-303cf08213e1 61 fields · synced Jul 23, 2026
- EUDAMED b306a844-76ed-4ba3-b1c4-15945eed5965 61 fields · synced May 18, 2026
- FDA UDI 3d13f98e-4f23-4f2f-9c37-c9f34697397f 32 fields · synced May 30, 2026