Data / Medical devices / United States / Tom's of Maine, Inc.
Tom's of Maine, Inc.: FDA-registered device maker in Sanford, ME, United States, 1 510(k) clearance
Tom's of Maine, Inc. is registered with the FDA (registration 1218077) in Sanford, ME, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 13, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1218077
- Address
- 27 Community Dr, Sanford, ME, United States, 04073
- Owner or operator
- Colgate-Palmolive Company (1218077)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- March 16, 2005
- Registered through
- 2026
- Brand names listed
- Tom's Naturally Waxed Flat Floss, Tom's of Maine Hydroxyapatite Gentle Mint, Tom's of Maine Sensitive + Rapid Relief Toothpaste, Tom's of Maine Sensitive + Whitening Toothpaste
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Floss, Dental | JES | 1 | Repackager or relabeler | accessdata.fda.gov |
| Varnish, Cavity | LBH | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| September 13, 2011 | K103461 | COLGATE DESENSITIZING DENTAL CREAM | LBH | Substantially Equivalent | Colgate-Palmolive Co. | accessdata.fda.gov |
Compare with other makers
Updated September 13, 2011. 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.