Registered with FDA
TOMY International, Inc.
Dyersville, IA, United States. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 4
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
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 | Manual Toothbrush | 2022 |
| Fluid-Filled Teething RingKKO · Class 2 | — | Lister | Liquid Filled Teether | 2022 |
| Teething Ring Non-Fluid FilledMEF · Class 1 | — | Lister | TEETHERThe First Years Teether, TFY Teething Trainer Cup | 2019 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| TOMY InternationalFDA reg. 3006852457 | Dyersville, IA, United States | Complaint file establishment |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9086544). 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.