Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012293198

FEI Number

3012293198

Entity Name

Haleon US HOLDINGS LLC

City/State/Country

Warren, NJ, US

Establishment Address

184 LIBERTY CORNER RD, Warren, NJ 07059, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Haleon (Owner Number: 2510369)

Owner / Operator Contact Address

184 Liberty Corner Road, --, Warren, NJ 07059, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Biotene Oral Balance Gel DENTURE CLEANSERS (VARIOUS) Polident Cleaner Polident POLIGRIP DENTURE CLEANSER TABLETS Polident Rapid Clean: Antibacterial Dental Appliance Cleanser Polident 3 Minute: Antibacterial Dental Appliance Cleanser Polident Overnight Whitening: Antibacterial Dental Appliance Cleanser Polident Smokers: Antibacterial Dental Appliance Cleanser Biotene Mouth Spray Sensodyne Sensitive Care Toothbrush Parodontax Toothbrush Sensodyne Pronamel Enamel Protection Medium Toothbrush Polident Denture Cleaner Brush parodontax COMPLETE PROTECTION TOOTHBRUSH Sensodyne Pronamel Intensive Enamel Repair Soft Toothbrush Sensodyne Sensitivity & Gum Soft Toothbrush

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LFD	Saliva, Artificial	Unknown	Class U	N/A	2011-11-03
EFT	Cleanser, Denture, Over The Counter	Dental	Class 1	872.3520	2002-04-30
LFD	Saliva, Artificial	Unknown	Class U	N/A	2011-11-03
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2010-10-21

Official Correspondent

Holly Schlaudecker

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Haleon

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1314819	Haleon US Holdings LLC	East Durham, NY, US
1000415764	Stafford-Miller Limited	DUNGARVAN Waterford, IE
1911445	Haleon US Inc.	Lincoln, NE, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K902838	Denture Dynamic'S, Inc.	DENTURE DYNAMIC'S DENTURE MAGIC	1990-09-06
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012293198. Last updated year: 2026. Please use registration number 3012293198 when referencing this establishment in official correspondence.