The following data is part of a premarket notification filed by Mk Meditech Inc. with the FDA for Atoz Mini-screw.
| Device ID | K210559 |
| 510k Number | K210559 |
| Device Name: | ATOZ Mini-Screw |
| Classification | Implant, Endosseous, Orthodontic |
| Applicant | MK Meditech Inc. Room# 511, 54, Changeop-ro, Sujeong-gu, Seongnam-si, KR 13449 |
| Contact | Sungchul Moon |
| Correspondent | Sungchul Moon MK Meditech Inc. Room# 511, 54, Changeop-ro, Sujeong-gu, Seongnam-si, KR 13449 |
| Product Code | OAT |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-25 |
| Decision Date | 2021-12-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800197900020 | K210559 | 000 |
| 08800197900334 | K210559 | 000 |
| 08800197900303 | K210559 | 000 |
| 08800197900297 | K210559 | 000 |
| 08800197900310 | K210559 | 000 |
| 08800197900099 | K210559 | 000 |
| 08800197900105 | K210559 | 000 |
| 08800197900112 | K210559 | 000 |
| 08800197900129 | K210559 | 000 |
| 08800197900136 | K210559 | 000 |
| 08800197900198 | K210559 | 000 |