510(k) K180718
- Device
- ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES
- Applicant
- TOMY, Inc.
- 510(k) number
- K180718
- Product code
- DYW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-10-30
- Date received
- 2018-03-19
- Regulation
- 872.5470
- Classification name
- Bracket, Plastic, Orthodontic
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jinichi Watanabe
- Address
- Tenko Bldg. 3-16-7 Midori-Cho, Fuchu City JP 183-0006 183-0006
FDA Registration Numbers#
- 9710611
- 1054415
- 3004109528
- 3006237499
- 3015272949
- 3008959450
- 9680845
- 9611458
- 1718476
- 2024980
- 2126683
- 2953749
- 3009646999
- 3032163716
- 1316408
- 3011788941
- 3032027578
- 3005695824
- 3003402534
- 3008796797
- 3030265369
- 3008882689
- 3013508670
- 8010342
- 3006430881
- 3012421607
- 1718912
- 2081322
- 3003678542
- 3007284437
Source Documents#
Other 510(k) Records For Product Code DYW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252760 | Carriere® Motion Pro® Clear Bite Corrector | Ortho Organizers, Inc. | 2025-11-27 |
| K251196 | Composite Orthodontic Brackets and Buttons | Ec Certification Service GmbH | 2025-04-21 |
| K201940 | Braces on Demand Bracket | Braces on Demand, Inc. | 2020-12-03 |
| K182338 | Blue Sky Bio Computerized Orthodontic Bracket System | Blue Sky Bio | 2018-11-09 |
| K160720 | Carriere Motion Clear Class II | Ortho Organizers, Inc. | 2016-11-28 |
| K150830 | CompleClear Plastic Orthodontic Bracket and Wire Appliance | Oracrew | 2016-08-26 |
| K150702 | Exceed Tx | Great Lakes Orthodontics, Ltd. | 2016-03-24 |
| K140807 | COMPOSITE ORTHODONTIC BRACKETS | Ortho Specialties | 2014-11-12 |
| K123118 | INSIGNIA DIGICAST | Ormco Corp. | 2013-03-26 |
| K123416 | INSIGNIA WITH ITERO | Ormco Corp. | 2013-03-13 |
| K121524 | INSIGNIA | Ormco Corp. | 2012-08-09 |
| K110796 | SIMPLICLEAR RECTANGULAR ORTHODONTIC WIRE | Biomers Products, LLC | 2011-03-31 |
| K101676 | CLEARARCH | Ormco Corp. | 2010-09-13 |
| K082207 | ORTHOCAD IQ | Cadent, Inc. | 2009-10-23 |
| K092030 | ELATION MB METAL REINFORCED PLASTIC BRACKET | Dentsply Interntional | 2009-07-24 |
Legacy Summary#
summary
FDA Review#
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