Manufacturer registered with FDA
Medimecca Co., Ltd.
Seoul, South Korea. Lists 6 dental device types with FDA across 1 registered establishment, and holds 4 510(k) clearances as applicant.
- Device types listed
- 6
- Brands and models
- 141
- 510(k) clearances
- 42013–2020
- Markets registered in
- 415 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2007–2026
Registered in 4 markets
Where regulators' registries name Medimecca Co., Ltd. as the manufacturer or the registration holder of a device.
RegisteredHome: South KoreaOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Medimecca Co., Ltd. | 4 clearances | 2013–2020 | Below |
| Australia | TGA | Manufacturer | Medimecca Co Ltd | 13 | 2021–2021 | Pure Global AI |
| China | NMPA | Registration holder | 美迪麦加有限公司MEDIMECCA Co.,Ltd. | 1 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | MEDIMECCA CO., LTD. | 1 | 2013–2013 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Medimecca Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | Biothread Dental Implant SystemBiothread Dental Implant SystemsCHAORUM Implant SystemDISOAR Implant SystemHonor'st ImplantHonorst Implant SystemM+ Implant SystemPh dentalUD Implant System | 2014 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | Biothread Dental Implant SystemBiothread Dental Implant SystemsCHAORUM Implant SystemDISOAR Implant SystemHonor'st ImplantHonorst Implant SystemM+ Implant SystemPh dentalUD Implant System | 2014 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | Cortical DrillDG00DSR (Disk-up Sinus Reamer)Guide (Point) DrillPILOT DRILLSidecut (Lindemann) DrillSinus+Cortical DrillSTOPPERTAP DRILLTaper Drill 1 moreTwist Drill | 2013 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Maker | DG00DSR (Disk-up Sinus Reamer) | 2009 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | HTD350HTD400HTD450HTD500HTD600PGD20SCD20TD2007TD2008TD2010 26 moreTD2011TD2013TD3508TD3510TD3511TD3513TD4007TD4008TD4010TD4011TD4013TD4507TD4508TD4510TD4511TD4513TD5007TD5008TD5010TD5011TD5013TD6007TD6008TD6010TD6011TD6013 | 2013 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Arman SEMI KITCHAORUM Full KITCHAORUM Implant System - AT Tray (various models)CHAORUM Implant System - Ball Abutment Driver (Various Models)CHAORUM Implant System - Ball Abutment Driver O-ring (Various Models)CHAORUM Implant System - Depth Gauge (Various Models)CHAORUM Implant System - Drill (various models)CHAORUM Implant System - Drill Extention (Various Models)CHAORUM Implant System - Drill Stopper (Various Models)CHAORUM Implant System - Driver Shaft (various models) 64 moreCHAORUM Implant System - Fixture Direction Pin (Various Models)CHAORUM Implant System - Fixture Drvier Adapter (Various Models)CHAORUM Implant System - Hand piece driver (various models)CHAORUM Implant System - Hand Piece Fixture Driver (Various Models)CHAORUM Implant System - Handle (various models)CHAORUM Implant System - Handpiece Drill Tip (various models)CHAORUM Implant System - Handpiece Driver Tip (various models)CHAORUM Implant System - Hex Hand & Ratchet Driver (Various Models)CHAORUM Implant System - Impression Coping (Various Models)CHAORUM Implant System - Impression Coping Screw (Various Models)CHAORUM Implant System - Lab Analog (Various Models)CHAORUM Implant System - Oring Abutment Driver (various models)CHAORUM Implant System - Parallel Pin (Various Models)CHAORUM Implant System - Pilot Drill (various models)CHAORUM Implant System - Plastic UCLA Abutment (Various Models)CHAORUM Implant System - Point Drill (Various Models)CHAORUM Implant System - PT Tray (various models)CHAORUM Implant System - Side Cut Drill (Various Models)CHAORUM Implant System - SUB PROTECTIVE CAP (various models)CHAORUM Implant System - Submerged Impression Coping Pick-up (various models)CHAORUM Implant System - Submerged Impression Coping Transfer (various models)CHAORUM Implant System - Submerged Plastic UCLA (various models)CHAORUM Implant System - SUGICAL KIT TRAY (various models)CHAORUM Implant System - Tab Drill (Various Models)CHAORUM Implant System - Tap Drill (various models)CHAORUM Implant System - Torque Wrench (Various Models)CHAORUM Implant System - Torque Wrench Fixture Driver (Various Models)CHAORUM Implant System - Trepan Drill (various models)CHAORUM Implant System - Twist Drill (Various Models)CHAORUM Implant System - Twist Drill Stopper (various models)CHAORUM Implant System -Hex Handpiece Driver (Various Models)CHAORUM SEMI KITCIS-T KITCIS-TSCustom KitEZ Guide KITEZ Guide Kit 1HD120(Tool)HONORST Full KITOnebody Implant Kit 1Onebody KITT1 Taper Guide KitT1 Taper KitUD Implant System - Ball Abutment Driver (Various Models)UD Implant System - Ball Abutment Driver O-ring (Various Models)UD Implant System - Depth Gauge (Various Models)UD Implant System - Drill Extention (Various Models)UD Implant System - Drill Stopper (Various Models)UD Implant System - Fixture Direction Pin (Various Models)UD Implant System - Fixture Driver Adapter (Various Models)UD Implant System - Hand Piece Fixture Driver (Various Models)UD Implant System - Hex Hand & Ratchet Driver (Various Models)UD Implant System - Hex Handpiece Driver (Various Models)UD Implant System - Impression Coping (Various Models)UD Implant System - Impression Coping Screw (Various Models)UD Implant System - Lab Analog (Various Models)UD Implant System - Parallel Pin (Various Models)UD Implant System - Point Drill (Various Models)UD Implant System - Side Cut Drill (Various Models)UD Implant System - Tab Drill (Various Models)UD Implant System - Torque Wrench (Various Models)UD Implant System - Torque Wrench Fixture Driver (Various Models)UD Implant System - Twist Drill (Various Models)UDISFK | 2013 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Medimecca Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 25 Sep 2020 | K202039 | Honorst Implant System | DZE Root-Form Endosseous Implant |
| 5 Jan 2017 | K160536 | Chaorum Implant System | DZE Root-Form Endosseous Implant |
| 5 Dec 2013 | K131682 | UD IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 21 Mar 2013 | K130221 | HERO II DENTAL IMPLANT SYSTEM, UI DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| MEDIMECCA CO LTDFDA reg. 3007649394 | Seoul, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10029396). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.