510(k) K201410
- Device
- VENUS Bracket, ROSE Bracket
- Applicant
- GNI Co., LTD
- 510(k) number
- K201410
- Product code
- NJM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-03-12
- Date received
- 2020-05-28
- Regulation
- 872.5470
- Classification name
- Bracket, Ceramic, Orthodontic
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Duk Soo Kim
- Address
- 5f 501, 63-12 Dongtancheomdansaneop 1-Ro Hwaseong KR 18469 18469
FDA Registration Numbers#
- 3005537733
- 3001561923
- 3032763783
- 9681207
- 1054415
- 3006291983
- 3003622434
- 3009438612
- 1937100
- 3027460334
- 9616044
- 3015272949
- 3022296393
- 3003971538
- 1815540
- 1000118628
- 9680845
- 1718476
- 2024980
- 2126683
- 3013641573
- 3005256634
- 2953749
- 3009646999
- 3006946041
- 3032163716
- 3015259864
- 3009402818
- 3008524225
- 3009011037
- 1316408
- 3004201548
- 3011788941
- 3009048384
- 3032027578
- 3010032042
- 3005695824
- 3016543896
- 3013508670
- 8010342
- 3008787992
- 3012421607
- 1833132
- 2081322
- 3003678542
- 3029683441
- 8044058
- 3007284437
- 3013410675
- 3014270297
Source Documents#
Other 510(k) Records For Product Code NJM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K232827 | LightForce Orthodontic System | Lightforce Orthodontics | 2023-09-14 |
| K232011 | Cleo | American Orthodontics | 2023-07-07 |
| K231635 | A-Line Advanced | Biocetec Co., Ltd. | 2023-06-06 |
| K230225 | DynaFlex Clear Brackets & Buttons | Dyna Flex | 2023-06-05 |
| K222847 | Ceramic Brackets Orthometric | Orthometric - Industria E Comercio DE Produtos Medicos | 2023-05-04 |
| K222764 | LightForce Orthodontic System | Lightforce Orthodontics | 2022-09-14 |
| K220689 | Vatech Clismile | Rayence Co., Ltd. | 2022-05-06 |
| K201038 | Luce Ceramic Bracket | Luce Castle Co., Ltd. | 2020-10-09 |
| K200148 | LightForce Orthodontic System (LFO System) | Lightforce Orthodontics | 2020-02-21 |
| K182672 | ROSA Bracket | Gni Co., Ltd. | 2019-11-15 |
| K192202 | Clear21 | World Class Technology Corporation | 2019-11-12 |
| K190608 | Mei Ceramic Bracket | Orthosun Co., Ltd. | 2019-11-04 |
| K180952 | Ceramic Bracket | Mem Dental Technology Co., Ltd. | 2019-06-07 |
| K182193 | S-Line | Biocetec Co., Ltd. | 2019-01-22 |
| K183542 | Signature Orthodontic System | Signature Orthodontics | 2019-01-02 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases