Data / Medical devices / United States / Procter & Gamble Co., Regulatory Affairs
Procter & Gamble Co., Regulatory Affairs: FDA-registered device maker in Mason, OH, United States, 3 510(k) clearances
Procter & Gamble Co., Regulatory Affairs is registered with the FDA (registration 1530449) in Mason, OH, United States. It lists 7 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 5, 2021. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 1530449
- FEI number
- 3000719926
- Address
- 8700 S Mason Montgomery RD., Mason, OH, United States, 45040
- Owner or operator
- Procter & Gamble (9915005)
- Roles
- Specification developer
- First device listed
- March 27, 1997
- Registered through
- 2027
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt | KOO | 1 | Specification developer | accessdata.fda.gov |
| Cleanser, Denture, Over The Counter | EFT | 1 | Specification developer | accessdata.fda.gov |
| Dental Hygiene Kit | NXZ | 1 | Specification developer | accessdata.fda.gov |
| Floss, Dental | JES | 1 | Specification developer | accessdata.fda.gov |
| Heat Source For Bleaching Teeth | EEG | 1 | Specification developer | accessdata.fda.gov |
| Pick, Massaging | JET | 1 | Specification developer | accessdata.fda.gov |
| Saliva, Artificial | LFD | U | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 5, 2021 | K203567 | Oral-B Dry Mouth Oral Rinse | LFD | Substantially Equivalent | The Procter & Gamble Company | accessdata.fda.gov |
| September 2, 2020 | K201277 | Oral-B Dry Mouth Oral Rinse | LFD | Substantially Equivalent | The Procter & Gamble Company | accessdata.fda.gov |
| January 28, 1993 | K925409 | ORAL-B DENTAL FLOSS WITH FLUORIDE | JES | Substantially Equivalent | Oral-B Laboratories | accessdata.fda.gov |
Compare with other makers
- All makers of Saliva, Artificial
- All makers of Floss, Dental
- All makers of Heat Source For Bleaching Teeth
- All makers of Dental Hygiene Kit
- All makers of Cleanser, Denture, Over The Counter
- All makers of Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt
Updated April 5, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.