ATOZ Mini-Screw
FDA 510(k) clearance K210559 · decided 2021-12-19
Clearance details
- K-number
- K210559
- Device name
- ATOZ Mini-Screw
- Applicant
- Mk Meditech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-02-25
- Decision date
- 2021-12-19
- Days to decision
- 297 days
- Clearance type
- Traditional
- Product code
- OAT
- Device class
- 2
- Regulation number
- 872.3640
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Seongnam-Si, KR
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| OrthoEasy Pal; OrthoEasy Pal Long Neck (K260268) | Bernhard Förster GmbH (Bernhard Foerster Ltd.) | 2026-05-19 |
| Leone Orthodontic Implant TAD (Temporary Anchorage Device) (K242944) | Leone S.P.A. | 2025-06-19 |
| Mini Screws (K231502) | Proimtech Saglik Urunleri Anonim Sirketi | 2024-09-04 |
| T-FIT (K231913) | Techwin Co., Ltd. | 2024-02-08 |
| ACR Screw System (K222245) | Biomaterials Korea, Inc. | 2023-08-21 |
| Mico One Orthodontic Screw (K202163) | Ze Fang Technology Co., Ltd. | 2022-10-07 |
| Ortholock Anchorage Devices (K202691) | Craniofacial Technologies, Inc. | 2022-04-28 |
| Ortho MI System (K211992) | Osteonic Co., Ltd. | 2021-10-15 |
| Syntec Orthodontic Mini Screw Extended System (K202790) | Syntec Scientific Corporation | 2021-09-17 |
| OBS Anchorage Screw, Biokey Anchorage Screw (K202278) | Bomei Co, Ltd. | 2021-01-08 |
| Blue Sky Bio TAD (K201919) | Blue Sky Bio, LLC | 2020-12-17 |
| Orthodontic Fixation Screw [Smart Anchor Miniscrew] (K191041) | Gni Co., Ltd. | 2020-08-28 |
Recalls involving this device
No recalls on record reference this clearance.