FDA Registration
Active
🇰🇷 South Korea
ACH Medical Co., Ltd.
Reg #: 3009848796
·
FEI: 3009848796
·
Expires 2026
Products
8
Proprietary Names
52
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- ACH Medical Co., Ltd.
- Registration Number
- 3009848796
- FEI Number
- 3009848796
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 28, Namyang-ro 930beon-gil, Namyang-eup
- City
- Hwaseong-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K200193
Owner / Operator
- Firm Name
- ACH Medical Co., Ltd.
- Operator Number
- 10043821
- Address
- 28, Namyang-ro 930beon-gil, Namyang-eup
- City
- Hwaseong-si
- State
- Gyeonggi
- Postal Code
- 18255
- Country
- KR
- Correspondent
- Se Hong Oh
US Agent
- Business Name
- LK Consulting Group USA, Inc.
- Contact Name
- Priscilla Chung
- Address
- 2552 Walnut Ave Ste 230
- City
- Tustin
- State
- CA
- ZIP
- 92780
- Country
- US
- [email protected]
- Phone
- 714 9225276
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2021-08-09 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2015-09-09 |
| Curette, Endodontic | EKT | Class 1 | Dental | No | 2013-07-26 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2015-09-09 |
| Drill, Dental, Intraoral | DZA | Class 1 | Dental | No | 2013-07-26 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2013-07-26 |
| File, Bone, Surgical | EMI | Class 1 | Dental | No | 2013-07-26 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2015-09-09 |
Proprietary Names
Zenex Fixture
IB-T
AIMGEN
Nexplant
Zenex Abutment
Kisses Plus Implant System
Biogenesis Implant System - Kisses
Zenex Pink Abutment
Zenex Implant Fixture
IB
Biogenesis Implant System - Aticon
Zenex Blue Abutment
Zenex Micro Thread Fixture
Serrated Curette
Pick-up impression coping
Abutment lab analog
Fixture lab analog
Ball lab analog
Plastic impression coping
Impression copin guide pin
Transfer impression coping
Diamond Lindermann drill
Step drill
Cortical drill
Sidecut drill
Straight drill
Twist drill
Pilot drill
Diamond 3D drill
Diamond Ossteotomy drill
Socket Bone File
Drill stopper
Bone collector extractor
Protect cap
Bone collector stopper
Octa driver
Drill extension
Machine screw driver
Ratchet wrench
Bone collector
Depth pin
Mount hold
Parallel pin
Torque wrench
Connector pin
Solid driver
Handpiece connector
Ratchet adaptor
Hex driver
Kisses Mini Implant System
IB Mini
Zenex Mini
Establishment Types
Manufacture Medical Device