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PaloDex KaVo ORTHOPANTOMOGRAPH™ OP 2D Digital Imaging System - HSA Registration DE0500704

Access comprehensive regulatory information for PaloDex KaVo ORTHOPANTOMOGRAPH™ OP 2D Digital Imaging System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0500704 and owned by Instrumentarium Dental, PaloDEx Group Oy. The device was registered on September 28, 2017.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS C
DE0500704
PaloDex KaVo ORTHOPANTOMOGRAPH™ OP 2D Digital Imaging System
HSA Registration Number: DE0500704
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Product Description

KaVo ORTHOPANTOMOGRAPH™ OP 2D is intended to be used for taking adult panoramic, child panoramic (reduced width), bitewing and TMJ exposures. Always use the lowest suitable x-ray dose to obtain the desired level of image quality.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0500704
Registration Date
September 28, 2017
Retention Due Date
September 27, 2026
Product Owner
Short Name
Instrumentarium Dental, PaloDEx Group Oy
Address
Nahkelantie 160, FI-04300 Tuusula, FINLAND
Registrant
Address
7500A BEACH ROAD, THE PLAZA, #09-303, SINGAPORE 199591
Importer
Address
13 STAMFORD ROAD, CAPITOL PIAZZA, #02-11, SINGAPORE 178905
Model Information
Model Name(s)
KAVO CHIN SUPPORT DISPOSABLE COVER KAVO BITE BLOCK DISPOSABLE COVER KAVO NASION SUPPORT DISPOSABLE COVER ORTHOPANTOMOGRAPH OP 2D KAVO LIP SUPPORT DISPOSABLE COVER
Model Identifier(s)
900509 900510 900511 901008 901011