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 |