Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1314819

FEI Number

1314819

Entity Name

Haleon US Holdings LLC

City/State/Country

East Durham, NY, US

Establishment Address

3169 Route 145, East Durham, NY 12423, US

Establishment Type(s)

Manufacture Medical Device

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

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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EFT	Cleanser, Denture, Over The Counter	Dental	Class 1	872.3520	2002-04-30

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
1000415764	Stafford-Miller Limited	DUNGARVAN Waterford, IE
3012293198	Haleon US HOLDINGS LLC	Warren, NJ, US
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

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3009211643	WEIHAI HUIHAI COMMODITY MANUFACTURE CO., LTD.	Weihai Shandong, CN
1821514	KULZER, LLC	SOUTH BEND, IN, US
3006186796	DENTSPLY NORTH AMERICA LLC	Lancaster, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1314819. Last updated year: 2026. Please use registration number 1314819 when referencing this establishment in official correspondence.