Identity
- Trade Name
- PriZma 3D Bio Splint Soft - Colorless (1000 g) FDA UDI
- Generic Name
- Dental appliance fabrication material, resin FDA UDI
- Device Name
- PRIZMA 3D BIO SPLINT SOFT is a UVA/UVB light cured resin exclusively for use in 3D printers. Indicated for the manufacted of night guards and splints. FDA UDI
- Model / Reference
- PRIZMA 3D BIO SPLINT FDA UDI
- Description
- PRIZMA 3D BIO SPLINT SOFT is a UVA/UVB light cured resin exclusively for use in 3D printers. Indicated for the manufacted of night guards and splints. FDA UDI
Identifiers
- Catalog Number
- 80483749008 FDA UDI
- Primary DI / UDI-DI
- 07898570928175 FDA UDI
- FDA Product Code
- KMY FDA UDI
- GMDN Term
- Dental appliance fabrication material, resin FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.5525 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
No
FDA UDI
Over-the-Counter
Yes
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 appliance fabrication material, resin
PriZma 3D Bio Splint Soft - Colorless (1000 g) by Maquira Industria de Produtos Odontologicos S/A — Class I — FDA UDI — listed in FDA GUDID
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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
- Maquira Industria de Produtos Odontologicos S/A
Sources (1)
- FDA UDI a42755fc-d1a1-4998-a46a-79add785081c 34 fields · synced Jun 8, 2026