Data / Medical devices / South Korea / ACH Medical Co., Ltd.
ACH Medical Co., Ltd.: FDA-registered device maker in Hwaseong-si Gyeonggi, South Korea, 5 510(k) clearances
ACH Medical Co., Ltd. is registered with the FDA (registration 3009848796) in Hwaseong-si Gyeonggi, South Korea. It lists 8 device types. The FDA files 5 510(k) clearances under its listings, the newest dated August 6, 2021. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3009848796
- Address
- 28, Namyang-ro 930beon-gil, Namyang-eup, Hwaseong-si Gyeonggi, South Korea, 18255
- Owner or operator
- ACH Medical Co., Ltd. (10043821)
- Roles
- Manufacturer
- First device listed
- March 25, 2013
- Registered through
- 2026
- Brand names listed
- AIMGEN, Abutment lab analog, Ball lab analog, Biogenesis Implant System - Aticon, Biogenesis Implant System - Kisses, Bone collector, Bone collector extractor, Bone collector stopper and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Manufacturer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Bur, Dental | EJL | 1 | Manufacturer | accessdata.fda.gov |
| Curette, Endodontic | EKT | 1 | Manufacturer | accessdata.fda.gov |
| Drill, Dental, Intraoral | DZA | 1 | Manufacturer | accessdata.fda.gov |
| File, Bone, Surgical | EMI | 1 | Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Manufacturer | accessdata.fda.gov |
| Tray, Impression, Preformed | EHY | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 6, 2021 | K200193 | Kisses Plus Implant System | NHA | Substantially Equivalent | Achimhai Medical Corporation | accessdata.fda.gov |
| April 3, 2018 | K172630 | Kisses Plus Implant System | DZE | Substantially Equivalent | Achimhai Medical Corporation | accessdata.fda.gov |
| October 6, 2017 | K170394 | Kisses Mini | DZE | Substantially Equivalent | Achimhai Medical Corporation | accessdata.fda.gov |
| July 31, 2015 | K142813 | Biogensis Implant System-Kisses | DZE | Substantially Equivalent | Biogenesis Co., Ltd. | accessdata.fda.gov |
| March 13, 2013 | K120089 | BIOGENESIS IMPLANT SYSTEM | DZE | Substantially Equivalent | Biogenesis Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Tray, Impression, Preformed
- All makers of File, Bone, Surgical
- All makers of Bur, Dental
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Implant, Endosseous, Root-Form
- All makers of Accessories, Implant, Dental, Endosseous
Updated August 6, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.