Data / Medical devices / United States / Colgate-Palmolive Company
Colgate-Palmolive Company: FDA-registered device maker in Piscataway, NJ, United States, 3 510(k) clearances
Colgate-Palmolive Company is registered with the FDA (registration 2218158) in Piscataway, NJ, United States. It lists 7 device types. The FDA files 3 510(k) clearances under its listings, the newest dated November 1, 2013. Registered through 2026. 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
- 2218158
- FEI number
- 2221095
- Address
- 909 River RD, Piscataway, NJ, United States, 08855
- Owner or operator
- COLGATE-PALMOLIVE COMPANY (2418748)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- August 28, 1978
- Registered through
- 2026
- Brand names listed
- 360, 360 Advanced Clean, 360 Advanced Floss Tip, 360 Advanced Optic White, 360 Advanced Whitening, 360 Charcoal, 360 Deep Clean, 360 Enamel Health and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | U | Complaint file establishment | accessdata.fda.gov |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Floss, Dental | JES | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Heat Source For Bleaching Teeth | EEG | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Toothbrush, Manual | EFW | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Toothbrush, Powered | JEQ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Varnish, Cavity | LBH | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| November 1, 2013 | K132109 | ENAMELAST | LBH | Substantially Equivalent | Ultradent Products Inc. / Oratech, LLC | accessdata.fda.gov |
| September 13, 2011 | K103461 | COLGATE DESENSITIZING DENTAL CREAM | LBH | Substantially Equivalent | Colgate-Palmolive Co. | accessdata.fda.gov |
| August 22, 2007 | K071703 | ELTA SILVER ANTIMICROBIAL WOUND GEL DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGIC | FRO | Substantially Equivalent | Swiss American Products, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Dressing, Wound, Drug
- All makers of Toothbrush, Manual
- All makers of Varnish, Cavity
- All makers of Heat Source For Bleaching Teeth
- All makers of Dressing, Wound, Hydrogel Without Drug And/Or Biologic
- All makers of Toothbrush, Powered
Updated November 1, 2013. 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.