PriZma 3D Bio Splint Soft - Colorless (250 g) (UDI PRIZMA 3D BIO SPLINT)
Manufactured by Maquira Industria de Produtos Odontologicos S/A
Device Regulatory Overview
The PriZma 3D Bio Splint Soft - Colorless (250 g) (Model/Catalog Number: PRIZMA 3D BIO SPLINT) is a medical device manufactured by Maquira Industria de Produtos Odontologicos S/A. This product is indexed under FDA Product Code / Category Classification KMY within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- PRIZMA 3D BIO SPLINT
- Product Code / EMDN
- KMY
- 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.
- Database Sync Date
- 2026-08-09 09:07:18
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of PriZma 3D Bio Splint Soft - Colorless (250 g)?
The registered manufacturer of record for PriZma 3D Bio Splint Soft - Colorless (250 g) is Maquira Industria de Produtos Odontologicos S/A.
What is the Primary UDI-DI identifier for PriZma 3D Bio Splint Soft - Colorless (250 g)?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is PRIZMA 3D BIO SPLINT.
What classification code is assigned to this device?
This device is registered under product classification code KMY.
Similar Classification Devices (KMY)
Other Devices by Maquira Industria de Produtos Odontologicos S/A
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