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Crosstex DentaPure® Dental Unit Water Purification Cartridge - HSA Registration DE0504553

Access comprehensive regulatory information for Crosstex DentaPure® Dental Unit Water Purification Cartridge in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0504553 and owned by Crosstex International Inc.. The device was registered on June 04, 2020.

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 B
DE0504553
Crosstex DentaPure® Dental Unit Water Purification Cartridge
HSA Registration Number: DE0504553
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Product Description

DentaPure® Dental Unit Water Purification Cartridge is for use on dental unit waterlines attached to the dynamic dental instruments. Used according to labelling, this cartridge reduces bacteria from the water supplied through the instruments to a level that will meet or exceed the current ADA recommendations for water quality having a maximum of 200 cfu/ml.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0504553
Registration Date
June 04, 2020
Change Notification Approval Date
January 08, 2025
Retention Due Date
June 03, 2025
Product Owner
Short Name
Crosstex International Inc.
Address
6789 W. Henrietta Road, Rush, NY 14543, UNITED STATES
Registrant
Address
5 ANG MO KIO INDUSTRIAL PARK 2A, AMK TECH II, #05-21, SINGAPORE 567760
Importer
Address
5 ANG MO KIO INDUSTRIAL PARK 2A, AMK TECH II, #05-21, SINGAPORE 567760
Model Information
Model Name(s)
DentaPure® DentaPure® DentaPure® DentaPure®
Model Identifier(s)
DPI365B DPI365B10 DPI365M DPI365M10