Manufacturer registered with FDA
Colgate-Palmolive Company
Piscataway, NJ, United States. Lists 5 dental device types with FDA across 6 registered establishments, and holds 6 510(k) clearances as applicant.
- Device types listed
- 5
- Brands and models
- 56
- 510(k) clearances
- 61982–2014
- Markets registered in
- 7104 registrations outside the US
- Establishments
- 6Brazil, China, Guatemala +2
510(k) clearances per year, 1980–2026
Registered in 7 markets
Where regulators' registries name Colgate-Palmolive Company as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Colgate-Palmolive Company | 6 clearances | 1982–2014 | Below |
| Colombia | INVIMA | Manufacturer | COLGATE SANXIAO CO. LTD.COLGATE SANXIAO CO. LTD · COLGATE SANXIAO CO., LTD · +2 | 82 | — | Pure Global AI |
| Brazil | ANVISA | Registration holder | COLGATE PALMOLIVE INDUSTRIAL LTDA | 11 | 2016–2024 | Pure Global AI |
| Australia | TGA | Registration holder | Colgate-Palmolive Pty LtdColgate Palmolive Industrial Ltda | 5 | 2009–2023 | Pure Global AI |
| Israel | AMAR | Manufacturer | Colgate Palmolive Industrial Ltda. | 4 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | COLGATE - PALMOLIVE INDUSTRIAL LTDA | 1 | 2007–2007 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | COLGATE-PALMOLIVE CO. | 1 | 2010–2010 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Colgate-Palmolive Company currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | CelloClassic CleanColgate Travel (Portable)Extra CleanGentle Gum CareGum ComfortGum ExpertGum HealthHelloHello Kids Toothbrush 41 moreKids 0-2 yearsKids 2-5 years (Kid SJ)Kids 2+Kids 2+ (Kid SJ)Kids 5+ (Kid MJ, Kids SJ, Kids SY)Kids 6+ years (Kids SY)Optic WhiteOptic White CharcoalOptic White PlatinumOptic White Pro SeriesPlusSensitive ExpertSlimSoftSlimSoft CharcoalTom's Antiplaque ToothbrushTom's Kids ToothbrushTom's Naturally CleanTom's WholecareTotal Advanced WhiteningTotal Foaming CleanTotal Plaque RemovalTotal WhiteningTriple Action CharcoalWaveWave Gum ComfortZig ZagZig Zag Charcoal360360 Advanced Clean360 Advanced Floss Tip360 Advanced Optic White360 Advanced Whitening360 Charcoal360 Deep Clean360 Enamel Health360 Fresh N Protect360 Sensitive360 Sensitive Advanced360 Whitening360 Whole Mouth Clean6+ Advanced Cavity Fighter | 1978 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | Colgate Waxed Dental FlossTom's Naturally Waxed Flat Floss | 1995 |
| Cavity VarnishLBH · Class 2 | Sealants & varnishes | Maker | Tom's of Maine Hydroxyapatite Gentle MintTom's of Maine Sensitive + Rapid Relief ToothpasteTom's of Maine Sensitive + Whitening Toothpaste | 2015 |
| Heat Source for Bleaching TeethEEG · Class 1 | Teeth whitening lights | Maker | — | 2018 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Maker | — | 2001 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Colgate-Palmolive Company as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 5 Jun 2014 | K140481 | COLGATE DESENSITIZING MOUTHRINSE, COLGATE SENSITIVE PRO-RELIEF MOUTHWASH | LBH Cavity Varnish |
| 13 Sep 2011 | K103461 | COLGATE DESENSITIZING DENTAL CREAM | LBH Cavity Varnish |
| 27 Apr 1995 | K944886 | COLGATE PRECISION MINT WZXED DENTAL FLOSS | JES Dental Floss |
| 15 Apr 1991 | K901955 | PERIOGARD(R) PERIOPEN | EFS Oral Irrigation Unit |
| 26 Aug 1988 | K883335 | COLGATE DENTAL FLOSS | JES Dental Floss |
| 12 Aug 1982 | K821685 | TOM'S NATURALLY WAXED FLOSSING TAPE | JES Dental Floss |
Also lists devices cleared under other names
Colgate-Palmolive Company lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Ultradent Products Inc. / Oratech, LLC (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 1 Nov 2013 | K132109 | ENAMELAST | Ultradent Products Inc. / Oratech, LLC | LBH Cavity Varnish |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| COLGATE SANXIAO CO., LTD.FDA reg. 3003205012 | Yangzhou Jiangsu, China | Manufacturer |
| Colgate-Palmolive (C.A.) S.A.FDA reg. 3008197908 | Zona 12 Guatemala, Guatemala | Manufacturer |
| Colgate-Palmolive CompanyFDA reg. 2218158 | PISCATAWAY, NJ, United States | Complaint file establishment, Specification developer |
| Colgate-Palmolive Company (Vietnam) Ltd - My Phuoc BranchFDA reg. 3008098744 | Ho Chi Minh City, Vietnam | Manufacturer |
| COLGATE-PALMOLIVE INDUSTRIAL LTDAFDA reg. 9613415 | Sao Paulo, Brazil | Foreign exporter, Manufacturer |
| Tom's of Maine, Inc.FDA reg. 1218077 | Sanford, ME, United States | Manufacturer, Repacker / relabeler |
Other names on FDA records
Tom'S of Maine, Inc. · Colgate - Palmolive Industrial Ltda · Colgate Palmolive (CA) S.A. · Colgate Sanxiao Co.ltd · Colgate-Palmolive Company (Vietnam) Ltd - My Phuoc Branch
Sources
FDA establishment registration & device listing (search FDA, owner/operator 2418748, 1218077). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.