Manufacturer registered with FDA
Procter & Gamble
Cincinnati, OH, United States. Lists 11 dental device types with FDA across 15 registered establishments, and holds 16 510(k) clearances as applicant.
- Device types listed
- 11
- Brands and models
- 0
- 510(k) clearances
- 161985–2020
- Markets registered in
- 8230 registrations outside the US
- Establishments
- 15China, Germany, Hungary +3
510(k) clearances per year, 1980–2026
Registered in 8 markets
Where regulators' registries name Procter & Gamble 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 | Procter & Gamble | 16 clearances | 1985–2020 | Below |
| Colombia | INVIMA | Manufacturer | PROCTER & GAMBLE MANUFACTURING MÉXICO S. DE R.L. DE C.V.THE PROCTER & GAMBLE COMPANY · PROCTER & GAMBLE MANUFACTURING GMBH · +2 | 191 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | PROCTER & GAMBLE INC.PROCTER & GAMBLE COMPANY | 19 | 1998–2019 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | PROCTER & GAMBLE CO.PROCTER & GAMBLE · PROCTER & GAMBLE COMPANY | 6 | 2010–2023 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | PROCTER & GAMBLE CO.BRAUN GMBH · PROCTER ＆ GAMBLE CO. | 6 | 2006–2019 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | THE PROCTER & GAMBLE COMPANYTHE PROCTER & GAMBLE | 4 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | THE PROCTER & GAMBLE CO. | 2 | 2017–2017 | Pure Global AI |
| Mexico | COFEPRIS | Registration holder | Procter & Gamble Manufacturing México, S. de R.L. de C.V. | 2 | 2012–2020 | 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 Procter & Gamble currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Maker | — | 2007 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | — | 2001 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | — | 1997 |
| Heat Source for Bleaching TeethEEG · Class 1 | Teeth whitening lights | Maker | — | 2016 |
| Over the Counter Denture CleanserEFT · Class 1 | Denture cleansers & adhesives | Maker | — | 1998 |
| Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt Denture AdhesiveKOO · Class 1 | Denture cleansers & adhesives | Maker | — | 1997 |
| Dental Hygiene KitNXZ · Class 1 | — | Maker | — | 2015 |
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Maker | — | 2007 |
| Massaging PickJET · Class 1 | Floss & interdental cleaners | Maker | — | 2007 |
| Oral Hygiene Rubber TipJEW · Class 1 | Floss & interdental cleaners | Maker | — | 2007 |
| Tongue ScraperLCN · Class 1 | — | Lister | — | 2007 |
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 Procter & Gamble as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 27 Aug 2020 | K200881 | Oral-B iO Test Drive Power Brush Trial Program Kit | JEQ Powered Toothbrush |
| 15 Sep 2014 | K141018 | ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER TOOTHBRUSH KIT, ORAL-B TEST DRIVE REFILL KIT | JEQ Powered Toothbrush |
| 24 Sep 2009 | K091964 | CREST GLIDE CLINICAL GUM PROTECTION DENTAL FLOSS | JES Dental Floss |
| 6 Feb 2008 | K073224 | ORAL-B SUB-BRAND MANUAL TOOTHBRUSH | EFW Manual Toothbrush |
| 5 Jun 2006 | K061351 | ORAL-B SONIC COMPLETE | JEQ Powered Toothbrush |
| 31 May 2006 | K061199 | ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIES | JEQ Powered Toothbrush |
| 11 Mar 1998 | K973236 | CREST TOOTHBRUSH WITH MICROSHIELD | EFW Manual Toothbrush |
| 27 Apr 1995 | K943157 | ORAL-B ULTRAFLOSS WITH FLLUORIDE | JES Dental Floss |
| 27 Apr 1995 | K942633 | ORAL-B INTERDENTAL WOODSTICKS WITH FLUORIDE | JET Massaging Pick |
| 30 Nov 1994 | K945200 | FIXODENT, FIXODENT FRESH, FASTEETH AND EXTRA HOLD FASTEETH DENTURE ADHESIVCES | KOO Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt Denture Adhesive |
| 9 Sep 1994 | K943182 | ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOR | EFS Oral Irrigation Unit |
| 29 Sep 1993 | K932990 | ORAL-B DISPOSABLE PROPHY ANGLE W/PROPHY CUP | EFB Dental Air-Powered Handpiece |
| 28 Jan 1993 | K925409 | ORAL-B DENTAL FLOSS WITH FLUORIDE | JES Dental Floss |
| 28 Jan 1993 | K925408 | ORAL-B DENTAL TAPE WITH FLUORIDE | JES Dental Floss |
| 26 Aug 1988 | K883024 | ORAL-B FLOSSERS | JES Dental Floss |
| 8 Feb 1985 | K844339 | BRAUN DENTAL CENTER OC-3 | EFS Oral Irrigation Unit |
Some of these clearances are listed with FDA today by another company: Twin River Group (4), New World Imports, Inc. (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Beijing Technology Co - Innovation CenterFDA reg. 3030192581 | Beijing, China | Specification developer |
| BRAUN (SHANGHAI) CO., LTD.FDA reg. 3002485596 | SHANGHAI, China | Manufacturer |
| Braun GmbHFDA reg. 3039398006 | Schwalbach/Ts Hesse, Germany | Specification developer |
| BRAUN GMBHFDA reg. 9617642 | KRONBERG Hesse, Germany | Specification developer |
| Gillette Diversified Operations (P) LtdFDA reg. 3007817025 | Mumbai Maharashtra, India | Foreign exporter |
| ORAL-B LABORATORIESFDA reg. 1910469 | IOWA CITY, IA, United States | Manufacturer |
| ORAL-B LABORATORIESFDA reg. 3013646822 | Iowa City, IA, United States | Manufacturer |
| PROCTER & GAMBLE CO.FDA reg. 1062366 | Brown Summit, NC, United States | Manufacturer |
| PROCTER & GAMBLE CO., REGULATORY AFFAIRSFDA reg. 1530449 | Mason, OH, United States | Specification developer |
| PROCTER & GAMBLE DISTRIBUTING LLC, THEFDA reg. 3011964664 | Union, OH, United States | Repacker / relabeler |
| Procter & Gamble Hyginett Kft.FDA reg. 3013504555 | Gyongyos Heves, Hungary | Manufacturer |
| Procter & Gamble Manufacturing GmbHFDA reg. 3000302531 | MARKTHEIDENFELD Bavaria, Germany | Manufacturer |
| PROCTER & GAMBLE MANUFACTURING GmbHFDA reg. 9617667 | GROSS-GERAU Hesse, Germany | Manufacturer |
| Procter & Gamble Manufacturing Mexico S. de R.L. de C.V.FDA reg. 9710651 | Estado de Mexico, C.P., Mexico | Manufacturer |
| The Procter & Gamble Distributing LLCFDA reg. 3021636076 | Morris, IL, United States | Repacker / relabeler |
Other names on FDA records
Braun GmbH · Oral B Laboratories · Procter & Gamble Hyginett KFT · Procter & Gamble Manufacturing GmbH · Procter & Gamble Manufacturing México, S. de R.L. de C.V. · Beijing Technology Co - Innovation Center · Procter & Gamble Co., Regulatory Affairs · The Procter & Gamble Distributing LLC · Gillette Diversified Operations (P) Ltd · Procter & Gamble Distributing LLC, the · Braun (Shanghai) Co., Ltd.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9915005). 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.