FDA Registration
Active
🇰🇷 South Korea
MEDIMECCA CO LTD
Reg #: 3007649394
·
FEI: 3007649394
·
Expires 2026
Products
6
Proprietary Names
130
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- MEDIMECCA CO LTD
- Registration Number
- 3007649394
- FEI Number
- 3007649394
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 104, 105, 109, 110, Daeryung Techno Town 3, 115, Gasan digital 2-ro, Geumcheon-gu
- City
- Seoul
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K160536
Owner / Operator
- Firm Name
- MEDIMECCA CO LTD
- Operator Number
- 10029396
- Address
- 104, 105, 109, 110, Daeryung Techno Town 3, 115, Gasan digital 2-ro, Geumcheon-gu
- City
- Seoul
- State
- KR-NOTA
- Postal Code
- 08505
- Country
- KR
- Correspondent
- Young Hyun Han
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 |
|---|---|---|---|---|---|
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2017-02-07 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2017-02-07 |
| Gauge, Depth, Instrument, Dental | EIL | Class 1 | Dental | No | 2009-05-10 |
| Drill, Dental, Intraoral | DZA | Class 1 | Dental | No | 2013-03-25 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2013-02-07 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2013-02-07 |
Proprietary Names
CHAORUM Implant System
M+ Implant System
Biothread Dental Implant System
Honor'st Implant
DISOAR Implant System
DG00
DSR (Disk-up Sinus Reamer)
Biothread Dental Implant Systems
UD Implant System
Guide (Point) Drill
Taper Drill
PILOT DRILL
Twist Drill
Sidecut (Lindemann) Drill
Sinus+Cortical Drill
STOPPER
Cortical Drill
TAP DRILL
TD6013
TD4008
TD6011
TD6008
TD4011
TD2013
TD3513
TD4511
TD4513
TD5008
TD2011
TD6007
TD5010
HTD500
HTD450
HTD400
TD2007
HTD600
TD4510
TD3508
TD5013
TD4508
TD5011
HTD350
TD5007
TD4007
TD2008
TD6010
TD4010
TD2010
PGD20
SCD20
TD4013
TD3511
TD4507
TD3510
Ph dental
Honorst Implant System
CHAORUM Implant System - Hex Hand & Ratchet Driver (Various Models)
CHAORUM Implant System - Drill Extention (Various Models)
CHAORUM Implant System - Impression Coping (Various Models)
CHAORUM Implant System - Hand Piece Fixture Driver (Various Models)
CHAORUM Implant System - Tab Drill (Various Models)
CHAORUM Implant System - Side Cut Drill (Various Models)
CHAORUM Implant System - Plastic UCLA Abutment (Various Models)
CHAORUM Implant System -Hex Handpiece Driver (Various Models)
UD Implant System - Impression Coping (Various Models)
CHAORUM Implant System - Fixture Drvier Adapter (Various Models)
CHAORUM Implant System - Ball Abutment Driver (Various Models)
CHAORUM Implant System - Lab Analog (Various Models)
CHAORUM Implant System - Depth Gauge (Various Models)
CHAORUM Implant System - Impression Coping Screw (Various Models)
CHAORUM Implant System - Ball Abutment Driver O-ring (Various Models)
UD Implant System - Drill Extention (Various Models)
CHAORUM Implant System - Drill Stopper (Various Models)
UD Implant System - Hex Hand & Ratchet Driver (Various Models)
CIS-T KIT
CHAORUM Implant System - Point Drill (Various Models)
CHAORUM Implant System - Torque Wrench Fixture Driver (Various Models)
UD Implant System - Drill Stopper (Various Models)
UDISFK
UD Implant System - Lab Analog (Various Models)
CHAORUM Implant System - Parallel Pin (Various Models)
UD Implant System - Depth Gauge (Various Models)
UD Implant System - Twist Drill (Various Models)
UD Implant System - Hand Piece Fixture Driver (Various Models)
CHAORUM Implant System - Fixture Direction Pin (Various Models)
UD Implant System - Impression Coping Screw (Various Models)
UD Implant System - Torque Wrench (Various Models)
UD Implant System - Ball Abutment Driver (Various Models)
CHAORUM Implant System - Torque Wrench (Various Models)
CHAORUM Implant System - SUGICAL KIT TRAY (various models)
CHAORUM Implant System - Twist Drill (Various Models)
UD Implant System - Point Drill (Various Models)
CHAORUM Implant System - Hand piece driver (various models)
CHAORUM Implant System - Submerged Impression Coping Transfer (various models)
CHAORUM Implant System - SUB PROTECTIVE CAP (various models)
CHAORUM Implant System - Drill (various models)
CHAORUM Implant System - Twist Drill Stopper (various models)
CHAORUM Implant System - Submerged Plastic UCLA (various models)
UD Implant System - Hex Handpiece Driver (Various Models)
UD Implant System - Tab Drill (Various Models)
UD Implant System - Fixture Driver Adapter (Various Models)
CHAORUM Implant System - Handpiece Driver Tip (various models)
CHAORUM Implant System - Trepan Drill (various models)
UD Implant System - Side Cut Drill (Various Models)
CIS-TS
UD Implant System - Torque Wrench Fixture Driver (Various Models)
UD Implant System - Ball Abutment Driver O-ring (Various Models)
HD120(Tool)
CHAORUM Implant System - Pilot Drill (various models)
UD Implant System - Parallel Pin (Various Models)
UD Implant System - Fixture Direction Pin (Various Models)
CHAORUM Implant System - Handpiece Drill Tip (various models)
CHAORUM Implant System - PT Tray (various models)
CHAORUM Implant System - AT Tray (various models)
CHAORUM Implant System - Oring Abutment Driver (various models)
CHAORUM Implant System - Handle (various models)
CHAORUM Implant System - Tap Drill (various models)
CHAORUM Implant System - Submerged Impression Coping Pick-up (various models)
CHAORUM Implant System - Driver Shaft (various models)
EZ Guide KIT
CHAORUM Full KIT
HONORST Full KIT
Onebody KIT
Arman SEMI KIT
CHAORUM SEMI KIT
Onebody Implant Kit 1
T1 Taper Kit
Custom Kit
T1 Taper Guide Kit
EZ Guide Kit 1
Establishment Types
Manufacture Medical Device