510(k) K222245
- Device
- ACR Screw System
- Applicant
- Biomaterials Korea, Inc.
- 510(k) number
- K222245
- Product code
- OAT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-08-21
- Date received
- 2022-07-26
- Regulation
- 872.3640
- Classification name
- Implant, Endosseous, Orthodontic
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Young-yeop Kim
- Address
- #329, #331, #413 150, Jojeong-Daero, Hanam-Si KR 12930 12930
FDA Registration Numbers
- 3022296393
- 3043841530
- 3018070878
- 1424785
- 9681207
- 3006034256
- 3004203816
- 9613348
- 3012477813
- 3015440604
- 9680963
- 3011530718
- 3015399803
- 3011302692
- 8044058
- 3015272949
- 9614404
- 2032098
- 3008559295
- 3005914490
- 3008812251
- 3005515228
- 3008524225
- 3017125693
- 3005562917
- 3010407203
- 3003394081
- 3008261720
- 2031093
- 3007515069
- 3034676720
- 3013508670
- 3007738812
- 9611458
- 3010596333
- 3004730002
- 8043792
- 3005728057
- 3016543896
- 3009732568
- 3008323540
- 3013701115
- 1424263
- 3013034344
- 1032347
- 3001561923
- 3014270297
- 3003402534
- 3013689189
- 3031886796
- 3008812560
- 3004049923
- 3012396434
- 3004158247
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Other 510(k) Records For Product Code OAT
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|---|---|---|---|
| K242944 | Leone Orthodontic Implant TAD (Temporary Anchorage Device) | Leone S.P.A. | 2025-06-19 |
| K231502 | Mini Screws | Proimtech Saglik Urunleri Anonim Sirketi | 2024-09-04 |
| K231913 | T-FIT | Techwin Co., Ltd. | 2024-02-08 |
| K202163 | Mico One Orthodontic Screw | Ze Fang Technology Co., Ltd. | 2022-10-07 |
| K202691 | Ortholock Anchorage Devices | Craniofacial Technologies, Inc. | 2022-04-28 |
| K210559 | ATOZ Mini-Screw | Mk Meditech, Inc. | 2021-12-19 |
| K211992 | Ortho MI System | Osteonic Co., Ltd. | 2021-10-15 |
| K202790 | Syntec Orthodontic Mini Screw Extended System | Syntec Scientific Corporation | 2021-09-17 |
| K202278 | OBS Anchorage Screw, Biokey Anchorage Screw | Bomei Co, Ltd. | 2021-01-08 |
| K201919 | Blue Sky Bio TAD | Blue Sky Bio, LLC | 2020-12-17 |
| K191041 | Orthodontic Fixation Screw [Smart Anchor Miniscrew] | Gni Co., Ltd. | 2020-08-28 |
| K190871 | Bio-TackS Orthodontic Mini Implant | Biocetec Co., Ltd. | 2020-01-17 |
| K182929 | BIO-RAY A-1 Anchor Screw System | Microware Precision Co., Ltd. | 2019-11-06 |
| K181142 | Absoanchor Microimplant | Dentos, Inc. | 2019-02-05 |
| K173623 | Anchor plate | Biomaterials Korea, Inc. | 2018-08-30 |