Identity
- Trade Name
- Bisi-Tray FDA UDI
- Generic Name
- Dental impression tray material FDA UDI
- Device Name
- A light curing material to be used to create a custom impression tray intended for filling with dental impression materials. Used in dentistry and in the laboratory. FDA UDI
- Model / Reference
- 03250 FDA UDI
- Description
- A light curing material to be used to create a custom impression tray intended for filling with dental impression materials. Used in dentistry and in the laboratory. FDA UDI
Identifiers
- Catalog Number
- 03250 FDA UDI
- Primary DI / UDI-DI
- EBIB032501 FDA UDI
- FDA Product Code
- EHY FDA UDI
- GMDN Term
- Dental impression tray material FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6880 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental impression tray material
Bisi-Tray by bisico Bielefelder Dentalsilicone GmbH & Co. KG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental impression tray material.
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- bisico Bielefelder Dentalsilicone GmbH & Co. KG
Sources (1)
- FDA UDI f578ce4f-361f-4210-8575-d9ea5c30edf6 36 fields · synced May 30, 2026