The following data is part of a premarket notification filed by F&b Technology Co., Ltd. with the FDA for Fit & Brilliant Dental Implant System.
| Device ID | K190637 |
| 510k Number | K190637 |
| Device Name: | Fit & Brilliant Dental Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | F&B Technology Co., Ltd. 17-230, #37, Kwaegam-ro, Sasang-ku, (Kwaebop, Ind. Supplies Market) Busan, KR 46977 |
| Contact | J H An |
| Correspondent | Ho Dong Yang Onbix Corporation #821 Samil Plaza, 14, Dogok-ro 1-gil, Gangnam-gu Seoul, KR 46977 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-12 |
| Decision Date | 2020-06-19 |