Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2218158

FEI Number

2221095

Entity Name

Colgate-Palmolive Company

City/State/Country

PISCATAWAY, NJ, US

Establishment Address

909 RIVER RD, PISCATAWAY, NJ 08855, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

COLGATE-PALMOLIVE COMPANY (Owner Number: 2418748)

Owner / Operator Contact Address

909 River Road, Piscataway, NJ 08855, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K132109

PMA Number

N/A

All Registered Proprietary Names

Kids 6+ years (Kids SY) Total Foaming Clean Kids 2+ (Kid SJ) Extra Clean Optic White Pro Series 360 Sensitive Kids 2-5 years (Kid SJ) Kids 2+ Kids 5+ (Kid MJ, Kids SJ, Kids SY) Total Advanced Whitening 360 Deep Clean Gum Expert 6+ Advanced Cavity Fighter Cello 360 Advanced Clean Wave 360 Whole Mouth Clean Optic White Total Plaque Removal Zig Zag Charcoal Zig Zag 360 Charcoal Colgate Travel (Portable) Optic White Platinum SlimSoft 360 Enamel Health Gum Health Classic Clean Gentle Gum Care Plus 360 Whitening Triple Action Charcoal 360 Advanced Floss Tip SlimSoft Charcoal Tom's Antiplaque Toothbrush 360 Advanced Optic White 360 Advanced Whitening Tom's Kids Toothbrush 360 Sensitive Advanced Hello Kids Toothbrush Wave Gum Comfort 360 Fresh N Protect Kids 0-2 years 360 Tom's Wholecare Optic White Charcoal Total Whitening Tom's Naturally Clean Gum Comfort Sensitive Expert EltaMD Silver Gel Colgate Waxed Dental Floss Tom's of Maine Sensitive + Rapid Relief Toothpaste Tom's of Maine Sensitive + Whitening Toothpaste

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	1978-08-28
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2022-05-30
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2001-07-18
EEG	Heat Source For Bleaching Teeth	Dental	Class 1	872.6475	2018-12-10
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2020-12-17
JES	Floss, Dental	Dental	Class 1	872.6390	1995-07-20
LBH	Varnish, Cavity	Dental	Class 2	872.3260	2015-02-23
LBH	Varnish, Cavity	Dental	Class 2	872.3260	2018-04-13

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

COLGATE-PALMOLIVE COMPANY

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3008197908	Colgate-Palmolive (C.A.) S.A.	Zona 12 Guatemala, GT
3003205012	COLGATE SANXIAO CO., LTD.	Yangzhou Jiangsu, CN
3008098744	Colgate-Palmolive Company (Vietnam) Ltd - My Phuoc Branch	Ho Chi Minh City, VN
9613415	COLGATE-PALMOLIVE INDUSTRIAL LTDA	Sao Paulo, BR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30
K882164	Arthur Blank & Co., Inc.	FLOSS CARD	1988-06-10
K033295	Novamin Technology, Inc.	BUTLER NUCARE ROOT CONDITIONER WITH NOVAMIN	2003-10-28

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

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3015913483	GRAND S KOREA CO., LTD.	Goyang-si Gyeonggi, KR
3043840120	CURIDENT, LLC	Boca Raton, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2218158. Last updated year: 2026. Please use registration number 2218158 when referencing this establishment in official correspondence.