Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003945201

FEI Number

3003945201

Entity Name

BAXTER LABORATORIES

City/State/Country

Boronia Victoria, AU

Establishment Address

1019 Mountain Hwy, Boronia Victoria 3155, AU

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Baxter Laboratories (Owner Number: 10095642)

Owner / Operator Contact Address

1019 Mountain Hwy, Boronia, AU-VIC 3155, AU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Pola Fresh Advanced Tooth Whitening and Cleansing Foam

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MAU	Eraser, Dental Stain	Dental	Class 1	872.6855	2026-04-08

Official Correspondent

Bob Blaschke

US Agent Details

Bob Blaschke Email: Bob@intlcosmetics.com Phone: (310) 5453223

Related Public Records

Same Entity

Baxter Laboratories

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003945201. Last updated year: 2026. Please use registration number 3003945201 when referencing this establishment in official correspondence.