Registered with FDA
TOMY International Inc.
Kowloon Bay, Hong Kong SAR China. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 5
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1Hong Kong SAR China
Devices listed with FDA
What TOMY International Inc. 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 | Lister | American Red CrossTOMY TOOTHBRUSH | 2010 |
| Fluid-Filled Teething RingKKO · Class 2 | — | Lister | TOMY, The First Years, LAMAZE/JOHN DEERE RING, TEETHING, FLUID-FILLED | 2010 |
| Teething Ring Non-Fluid FilledMEF · Class 1 | — | Lister | TEETHING, NON-FLUID FILLEDTFY Teething Trainer Cup | 2010 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
TOMY International Inc. 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: Fu Hong Industries , Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 14 Dec 2005 | K052531 | FU HONG INDUSTRIES LIMITED SOOTHER TEETHER | Fu Hong Industries , Ltd. | KKO Fluid-Filled Teething Ring |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| TOMY (Hong Kong) LimitedFDA reg. 3008687634 | Kowloon, Hong Kong, Hong Kong SAR China | Foreign exporter |
Other names on FDA records
TOMY (Hong Kong) Limited
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10033889). 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.