The following data is part of a premarket notification filed by Dentis Co.,ltd. with the FDA for Dentis Dental Implant System.
Device ID | K171027 |
510k Number | K171027 |
Device Name: | Dentis Dental Implant System |
Classification | Implant, Endosseous, Root-form |
Applicant | Dentis Co.,Ltd. 99, Seongseoseo-ro, Dalseo-gu Daegu, KR 42718 |
Contact | Sun Chul Shin |
Correspondent | April Lee WithUS Group Inc 2531 Pepperdale Drive Rowland Heights, CA 91748 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-04-05 |
Decision Date | 2017-09-06 |
Summary: | summary |