Cartridge (box) containing one pot with Digital Sensor Cone Positioner

FDA UDI

Class I (US FDA UDI)

by Maquira Industria de Produtos Odontologicos S/A

Identity

Trade Name: Cartridge (box) containing one pot with Digital Sensor Cone Positioner FDA UDI
Generic Name: Radiological general body-part positioner FDA UDI
Device Name: Cone Positioner for Digital Sensor is a polyacetal-based product indicated for the precise orientation of X-ray machines in dental procedures. FDA UDI
Model / Reference: PriZma 3D Bio Ortho FDA UDI
Description: Cone Positioner for Digital Sensor is a polyacetal-based product indicated for the precise orientation of X-ray machines in dental procedures. FDA UDI

Identifiers

Catalog Number: 80322400150 FDA UDI
Primary DI / UDI-DI: 07898561549150 FDA UDI
FDA Product Code: EGZ FDA UDI
GMDN Term: Radiological general body-part positioner FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.1905 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Radiological general body-part positioner

Cartridge (box) containing one pot with Digital Sensor Cone Positioner by Maquira Industria de Produtos Odontologicos S/A — Class I — FDA UDI — listed in FDA…

Similar devices

Also classified as Radiological general body-part positioner.

Oakworks Medical — OAKWORKS, INC. · Class II
AADCO — AADCO MEDICAL, INC. · Class I
Techno-Aide — TECHNO-AIDE, INC. · Class I
Techno-Aide — TECHNO-AIDE, INC. · Class I
Techno-Aide — TECHNO-AIDE, INC. · Class I
pearltec — Pearl Technology AG · Class I
AADCO — AADCO MEDICAL, INC. · Class I
Oakworks Medical — OAKWORKS, INC. · Class II

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Maquira Industria de Produtos Odontologicos S/A

Sources (1)

FDA UDI 7a5ba5e2-3d3b-4169-9a49-2e55f0981e7c 34 fields · synced May 30, 2026