The following data is part of a premarket notification filed by Dentos Inc with the FDA for Absoanchor Microimplant.
Device ID | K181142 |
510k Number | K181142 |
Device Name: | Absoanchor Microimplant |
Classification | Implant, Endosseous, Orthodontic |
Applicant | Dentos Inc 41, Seongseo-ro 68-gil, Dalseo-gu Daegu, KR 42697 |
Contact | Kim Jin-hyun |
Correspondent | Yang Ho Dong Onbix Corporation #821 Samil Plaza, 14, Dogok-ro 1-gil, Gangnam-gu Seoul, KR 06253 |
Product Code | OAT |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-05-01 |
Decision Date | 2019-02-05 |