The following data is part of a premarket notification filed by Arumdentistry Co., Ltd. with the FDA for Nb 1 Sa Implant System.
Device ID | K213506 |
510k Number | K213506 |
Device Name: | NB 1 SA Implant System |
Classification | Implant, Endosseous, Root-form |
Applicant | Arumdentistry Co., Ltd. 1-dong, 44, Techno 8-ro, Yuseong-gu Daejeon, KR 34028 |
Contact | Hyang Mi Lee |
Correspondent | April Lee Withus Group Inc 106 Superior Irvine, CA 92620 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-11-01 |
Decision Date | 2022-04-06 |