The following data is part of a premarket notification filed by Arum Dentistry Co., Ltd with the FDA for C&b 5.0 Hybrid.
| Device ID | K210817 |
| 510k Number | K210817 |
| Device Name: | C&B 5.0 Hybrid |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | Arum Dentistry Co., Ltd 44, Techno 8-ro, Yuseong-gu Daejeon, KR 34028 |
| Contact | Yongsup Lee |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 1150 Roosevelt, STE 200 Irvine, CA 92620 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-18 |
| Decision Date | 2021-12-08 |