Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3032823828

FEI Number

3032823828

Entity Name

CBE PURE SOLUTIONS PTY LTD

City/State/Country

Ferntree Gully Victoria, AU

Establishment Address

5 William Street, Ferntree Gully Victoria 3156, AU

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

CBE Pure Solutions Pty Ltd (Owner Number: 10094068)

Owner / Operator Contact Address

5 William Street, Ferntree Gully, AU-VIC 3156, AU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K222560

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LFC	Device, Caries Detection	Dental	Class 2	872.1740	2025-11-16

Official Correspondent

Andrew Hoxey

US Agent Details

Gregory Plunkett Business: Accelcro llc Email: greg.plunkett@accelagen.com.au Phone: (646) 2562250

Related Public Records

Same Entity

CBE Pure Solutions Pty Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Similar Registrations

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3002807420	KURARAY NORITAKE DENTAL NIIGATA PLANT	TAINAI Niigata, JP
3038718579	OKETZ LOGISTICS LLC	Coral Gables, FL, US
1718912	Ultradent Products Inc.	South Jordan, UT, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3032823828. Last updated year: 2026. Please use registration number 3032823828 when referencing this establishment in official correspondence.