The following data is part of a premarket notification filed by Genoss Co., Ltd. with the FDA for Bright Bond Universal.
| Device ID | K200153 |
| 510k Number | K200153 |
| Device Name: | Bright Bond Universal |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | GENOSS Co., Ltd. 1F, Gyeonggi R&DB Center, 105 Gwanggyo-ro, Yeongtong-gu, Suwon-si Suwon-si, KR 16229 |
| Contact | Hong Jun Jeon |
| Correspondent | Hong Jun Jeon GENOSS Co., Ltd. 1F, Gyeonggi R&DB Center, 105 Gwanggyo-ro, Yeongtong-gu, Suwon-si Suwon-si, KR 16229 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-22 |
| Decision Date | 2020-10-28 |