Data / Medical devices / Japan / Tomy, Inc.
Tomy, Inc.: FDA-registered device maker in Iwaki City Fukushima, Japan, 3 510(k) clearances
Tomy, Inc. is registered with the FDA (registration 8010342) in Iwaki City Fukushima, Japan. It lists 12 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 30, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8010342
- FEI number
- 3002853098
- Address
- 100-1 Bessho, Jobanfujiwaramachi, Iwaki City Fukushima, Japan, 972-8326
- Owner or operator
- TOMY, INC. (8010342)
- Roles
- Manufacturer
- First device listed
- March 1, 1978
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Band, Material, Orthodontic | DYO | 1 | Manufacturer | accessdata.fda.gov |
| Band, Preformed, Orthodontic | ECM | 1 | Manufacturer | accessdata.fda.gov |
| Bracket, Ceramic, Orthodontic | NJM | 2 | Manufacturer | accessdata.fda.gov |
| Bracket, Metal, Orthodontic | EJF | 1 | Manufacturer | accessdata.fda.gov |
| Bracket, Plastic, Orthodontic | DYW | 2 | Manufacturer | accessdata.fda.gov |
| Clamp, Wire, Orthodontic | ECN | 1 | Manufacturer | accessdata.fda.gov |
| Clasp, Preformed | EHP | 1 | Manufacturer | accessdata.fda.gov |
| Facebow | KCR | 1 | Manufacturer | accessdata.fda.gov |
| Retainer, Screw Expansion, Orthodontic | DYJ | 1 | Manufacturer | accessdata.fda.gov |
| Spring, Orthodontic | ECO | 1 | Manufacturer | accessdata.fda.gov |
| Tube, Orthodontic | DZD | 1 | Manufacturer | accessdata.fda.gov |
| Wire, Orthodontic | DZC | 1 | 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 |
|---|---|---|---|---|---|---|
| October 30, 2018 | K180718 | ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES | DYW | Substantially Equivalent | Tomy, Inc. | accessdata.fda.gov |
| August 26, 2016 | K160615 | ORTHODONTIC CERAMIC BRACKETS 1.1 | NJM | Substantially Equivalent | Tomy, Inc. | accessdata.fda.gov |
| December 21, 2012 | K123092 | CERAMIN BRACKETS Z | NJM | Substantially Equivalent | Tomy, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Wire, Orthodontic
- All makers of Clasp, Preformed
- All makers of Bracket, Metal, Orthodontic
- All makers of Spring, Orthodontic
- All makers of Band, Preformed, Orthodontic
- All makers of Clamp, Wire, Orthodontic
Updated October 30, 2018. 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.