Manufacturer registered with FDA
HUMEDITECH Co., Ltd
Gimhae-si, South Korea. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 34
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1South Korea
Devices listed with FDA
What HUMEDITECH 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 |
|---|---|---|---|---|
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | C-Bone PackerDrill ExtensionFixture Driver Long and ShortG-PackerG-RemoverInitial DrillKimplant KITKimplant KIT caseLance DrillNoMount Driver Long and Short 24 moreNRG KIT_Guide Taper Drill, Guide Point Drill, Guide Initial DrillNRG KIT_Guide Tissue Punch, Drill Guide, Guide Fixture Driver, Drill ExtensionParallel PinPlastic CapPNUADD Taper Surgical KIT_Fixture Driver, Depth Gauge, Torque RatchetPNUADD Taper Surgical KIT_Lance Drill, Lindemann Drill, Drill Extension, Straight Drill, Taper Surgical DrillPNUADD Taper Surgical KIT_Taper Cortical Drill, Parallel Pin, Hand Driver, Ratchet Driver, No Mount DriverSG KIT_Fixture Driver, Hand Driver, Mount Driver, Lateral Anchor Drill, Lateral Anchor DriverSG KIT_Guide Initial Drill, Guide Taper Drill, Guide Point Drill, Guide Tissue PunchSG KIT_Lateral Anchor Screw, Vertical Anchor Screw, Torque Wrench, Drill Guide, Guide Counter SinkSun-Bone PackerTaper Cortical DrillTaper DrillTG KIT_Guide Fixture Driver, Bone Profiler, Vertical Anchor Screw, Drill Guide, Mount Driver, Hand DriverTG KIT_Guide Point Drill, Guide Initial Drill, Guide Step Drill, Guide Taper Drill, Guide Tissue PunchTG KIT_Lateral Anchor Drill, Lateral Anchor Driver, Lateral Anchor Screw, Torque WrenchThree Cutter Twist DrillTissue PunchTorque ExtensionTorque WrenchTwist DrillUG KIT_Drill Guide, Lateral Anchor Drill, Lateral Anchor Driver, Lateral Anchor Screw, Torque WrenchUG KIT_Guide Point Drill, Guide Initial Drill, Guide Straight Drill, Guide Tissue Punch, Bone Profiler1.2 Hex. Driver Long and Short | 2024 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| HUMEDITECH CO., LTDFDA reg. 3012564447 | Gimhae-si Gyeongnam, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10091775). 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.