The following data is part of a premarket notification filed by Tomy, Inc. with the FDA for Orthodontic Plastic Brackets And Accessories.
| Device ID | K180718 |
| 510k Number | K180718 |
| Device Name: | ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES |
| Classification | Bracket, Plastic, Orthodontic |
| Applicant | TOMY, Inc. Tenko Bldg. 3-16-7 Midori-cho, Fuchu City, JP 183-0006 |
| Contact | Jinichi Watanabe |
| Correspondent | Ruthanne Vendy Regulatory & Quality Solutions, Inc. 2790 Mosside Blvd. #800 Monroeville, PA 15146 |
| Product Code | DYW |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-19 |
| Decision Date | 2018-10-30 |
| Summary: | summary |