Identity
- Trade Name
- BISICO Function EUDAMEDFDA UDI
- Generic Name
- Silicone dental impression material FDA UDI
- Device Name
- BISICO Function EUDAMEDAddition-curing dental impression silicone FDA UDI
- Model / Reference
- 01350 EUDAMEDFDA UDI
- Description
- Addition-curing dental impression silicone FDA UDI
Identifiers
- Catalog Number
- 01350 FDA UDI
- Primary DI / UDI-DI
- +EBIB013501 EUDAMEDEBIB013501 FDA UDI
- Basic UDI-DI
- B-+EBIB013501 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 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Category: Silicone dental impression material
BISICO Function by bisico Bielefelder Dentalsilicone GmbH & Co. KG — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Silicone dental impression material.
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- 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 Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- bisico Bielefelder Dentalsilicone GmbH & Co. KG
Sources (2)
- FDA UDI 2849a3a4-7324-4284-824f-a366045a6b6f 36 fields · synced Oct 8, 2026
- EUDAMED d364e9d9-8a08-45fc-a8e3-c792f80178c9 61 fields · synced Oct 8, 2026