Manufacturer registered with FDA
Tomy, Inc.
Fuchu City, Japan. Lists 12 dental device types with FDA across 1 registered establishment, and holds 4 510(k) clearances as applicant.
- Device types listed
- 12
- Brands and models
- 0
- 510(k) clearances
- 42012–2018
- Markets registered in
- 418 registrations outside the US
- Establishments
- 1Japan
510(k) clearances per year, 2007–2026
Registered in 4 markets
Where regulators' registries name Tomy, Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Tomy, Inc. | 4 clearances | 2012–2018 | Below |
| Taiwan | TFDA | Manufacturer | TOMY CORPORATIONTOMY INCORPORATED · Tomy Incorporated | 12 | 2005–2016 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | TOMY INCTOMY INCORPORATED · TOMY, INC, | 5 | 2014–2026 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | TOMY, INC. | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Tomy, 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 |
|---|---|---|---|---|
| Orthodontic Ceramic BracketNJM · Class 2 | Orthodontic brackets | Maker | — | 2013 |
| Orthodontic Screw Expansion RetainerDYJ · Class 1 | Retainers, expanders & headgear | Maker | — | 2013 |
| Orthodontic Material BandDYO · Class 1 | Orthodontic wires & bands | Maker | — | 1978 |
| Orthodontic Plastic BracketDYW · Class 2 | Orthodontic brackets | Maker | — | 2018 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | — | 1981 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Maker | — | 1978 |
| Orthodontic Preformed BandECM · Class 1 | Orthodontic wires & bands | Maker | — | 1978 |
| Orthodontic Wire ClampECN · Class 1 | — | Maker | — | 2013 |
| Orthodontic SpringECO · Class 1 | Orthodontic wires & bands | Maker | — | 2013 |
| Preformed ClaspEHP · Class 1 | — | Maker | — | 2013 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | — | 1978 |
| FacebowKCR · Class 1 | Articulators & facebows | Maker | — | 1978 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Tomy, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 30 Oct 2018 | K180718 | ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES | DYW Orthodontic Plastic Bracket |
| 26 Aug 2016 | K160615 | ORTHODONTIC CERAMIC BRACKETS 1.1 | NJM Orthodontic Ceramic Bracket |
| 21 Dec 2012 | K123092 | CERAMIN BRACKETS Z | NJM Orthodontic Ceramic Bracket |
| 13 Dec 2012 | K123094 | ORTHODONTIC CERAMIC BRACKETS | NJM Orthodontic Ceramic Bracket |
Some of these clearances are listed with FDA today by another company: GC Orthodontics (2).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| TOMY, INC.FDA reg. 8010342 | Iwaki City Fukushima, Japan | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8010342). 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.