The following data is part of a premarket notification filed by Surgident Co., Ltd. with the FDA for Sd Abutment.
Device ID | K173570 |
510k Number | K173570 |
Device Name: | SD Abutment |
Classification | Abutment, Implant, Dental, Endosseous |
Applicant | Surgident Co., Ltd. #209-210, Woolim Lion's Valley, 27, Dunchon-daero 457beon-gil, Jungwon-gu Seongnam-si, KR 13229 |
Contact | Ju Youn Choi |
Correspondent | Peter Chung Plus Global 300 Atwood Street Pittsburgh, PA 15213 |
Product Code | NHA |
CFR Regulation Number | 872.3630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-11-20 |
Decision Date | 2019-05-17 |
Summary: | summary |