Manufacturer registered with FDA
DIMPLO Ltd.
Yeonje-gu, South Korea. Lists 4 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 4
- Brands and models
- 74
- 510(k) clearances
- 12025–2025
- Markets registered in
- 1United States
- Establishments
- 1South Korea
510(k) clearances per year, 2007–2026
Devices listed with FDA
What DIMPLO 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 |
|---|---|---|---|---|
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | Anchor DrillBone Flat DrillCore DrillCortical DrillFinal DrillGuide Final DrillGuide Initial DrillGuide Path DrillGuide Sinus Final DrillGuide Sinus Round Drill 8 moreGuide Socket DrillGuide Step DrillInitial DrillLance DrillRound DrillSidecut DrillTaper DrillTwist Drill | 2026 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | DIMPLO Implant System | 2026 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Adapter ExtensionAnchor DriverAnchor ScrewAngled Sinus ElevatorASC DriverBone CondenserBone Condenser - SinusBone ProfilerC Stopper 10mmC Stopper 11mm 44 moreC Stopper 12mmC Stopper 1mmC Stopper 2mmC Stopper 3mmC Stopper 4mmC Stopper 5mmC Stopper 6mmC Stopper 7mmC Stopper 8mmC Stopper 9mmC Stopper HolderCarrierDepth GaugeDepth Gauge - SinusDrill ExtensionFixture DriverGuidaz KitHandleHex DriverL Stopper 0.5mmL Stopper 1.5mmL Stopper 1mmL Stopper 2.5mmL Stopper 2mmL Stopper 3mmL Stopper HolderMembrane LifterMembrane Lifter SyringeMembrane Lifter TubeMulti Abut DriverMushroom Sinus ElevatorParallel PinProsthetic KitSinus Curette (Medium)Sinus Curette (Small)Sinus Guidaz KitSinus Lift KitSinus Master KitSquare WrenchSurgical Taper KitSurgical Wide KitTissue PunchTorque WrenchWide Sinus Elevator | 2026 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | DIMPLO Implant System | 2026 |
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 |
|---|---|---|
| DIMPLO Ltd.FDA reg. 3042971970 | Yeonje-gu Busan, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10094913). 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.