The following data is part of a premarket notification filed by Neobiotech Co., Ltd. with the FDA for Is Multi Unit Abutment System.
| Device ID | K210903 |
| 510k Number | K210903 |
| Device Name: | IS Multi Unit Abutment System |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Neobiotech Co., Ltd. #204, 36, Digital-ro 27gil, Guro-gu Seoul, KR 08381 |
| Contact | Young-ku Heo |
| Correspondent | April Lee Withus Group Inc 106 Superior Irvine, CA 92620 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-26 |
| Decision Date | 2021-07-23 |