Identity
- Trade Name
- PriZma 3D Bio Guide - Ambar (1000 g) FDA UDI
- Generic Name
- Dental guided surgery reference plate FDA UDI
- Device Name
- PRIZMA 3D BIO GUIDE is a UVA/UVB light cured resin exclusively for use in 3D printers. Indicated for the manufacted of surgical guides for implants and others. FDA UDI
- Model / Reference
- PriZma 3D Bio Guide FDA UDI
- Description
- PRIZMA 3D BIO GUIDE is a UVA/UVB light cured resin exclusively for use in 3D printers. Indicated for the manufacted of surgical guides for implants and others. FDA UDI
Identifiers
- Catalog Number
- 80483740003 FDA UDI
- Primary DI / UDI-DI
- 07898561547019 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Dental guided surgery reference plate FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3980 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 guided surgery reference plate
PriZma 3D Bio Guide - Ambar (1000 g) by Maquira Industria de Produtos Odontologicos S/A — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental guided surgery reference plate.
- DIOnavi. Surgical Guide — DIO Corporation · Class I
- DIOnavi. Surgical Guide — DIO Corporation · Class I
- DIOnavi. Surgical Guide — DIO Corporation · Class I
- EZ Stent — APPLIED DENTAL, INC. · Class I
- DIOnavi. Surgical Guide — DIO Corporation · Class I
- DIOnavi. Guide (Anchor system) — DIO Corporation · Class I
- DIOnavi. Surgical Guide — DIO Corporation · Class I
- DIOnavi. Surgical Guide — DIO Corporation · Class I
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 23756595-c700-4146-be2d-efeb014a1f51 34 fields · synced May 31, 2026