The following data is part of a premarket notification filed by Snucone Co., Ltd. with the FDA for Snucone Bone Level Implant System.
Device ID | K210354 |
510k Number | K210354 |
Device Name: | SNUCONE Bone Level Implant System |
Classification | Implant, Endosseous, Root-form |
Applicant | SNUCONE Co., LTD. 5, Seongseo-ro 75-gil Dalseo-gu, KR 42703 |
Contact | Ji Eun Song |
Correspondent | Sanglok Lee Wise Company Inc. #507, #508, 166 Gasan Digital 2-ro Geumcheon-gu, KR 08503 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-02-08 |
Decision Date | 2022-07-13 |