Identity
- Trade Name
- BISICO S1 Suhy EUDAMEDFDA UDI
- Generic Name
- Silicone dental impression material FDA UDI
- Device Name
- BISICO Addition-curing dental impression silicone EUDAMEDBISICO S1 Suhy EUDAMEDAddition-curing dental impression silicone FDA UDI
- Model / Reference
- 01090 EUDAMEDFDA UDI
- Description
- Addition-curing dental impression silicone FDA UDI
Identifiers
- Catalog Number
- 01090 FDA UDI
- Primary DI / UDI-DI
- +EBIB010901 EUDAMEDEBIB010901 FDA UDI
- Basic UDI-DI
- ++EBIB019SILI7U EUDAMEDB-+EBIB010901 EUDAMED
- Direct Marketing DI
- +EBIB010901 EUDAMED
- FDA Product Code
- ELW FDA UDI
- EMDN Code
- Q01020104 DENTAL IMPRESSION SILICONES EUDAMED
- GMDN Term
- Silicone dental impression material FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3660 FDA UDI
- Market of Registration
- Germany 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
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
BISICO S1 Suhy by bisico Bielefelder Dentalsilicone GmbH & Co. KG — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++EBIB019SILI7U | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | ++EBIB019SILI7U | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bisico Bielefelder Dentalsilicone GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000011554
Sources (3)
- EUDAMED 2efb01ef-8a91-4055-97d3-3e9c54917494 61 fields · synced Oct 6, 2026
- EUDAMED a541bfcf-1b1c-4241-8176-86f3990cc7ab 61 fields · synced May 11, 2026
- FDA UDI 53afb14d-7a15-4561-b4a8-a868b1889e39 36 fields · synced May 29, 2026