Manufacturer registered with FDA
Ossvis Co., Ltd.
Anyang-si, South Korea. Lists 12 dental device types with FDA across 1 registered establishment, and holds 7 510(k) clearances as applicant.
- Device types listed
- 12
- Brands and models
- 173
- 510(k) clearances
- 72023–2024
- Markets registered in
- 332 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2007–2026
Registered in 3 markets
Where regulators' registries name Ossvis 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 | Ossvis Co., Ltd. | 7 clearances | 2023–2024 | Below |
| European Union | EUDAMED | Manufacturer | Ossvis Co., Ltd. | 27 | — | Pure Global AI |
| China | NMPA | Registration holder | 奥斯比斯种植体有限公司Ossvis Co., Ltd. | 5 | — | 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 Ossvis 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 AbutmentNHA · Class 2 | Implant abutments | Maker | LL Implant SystemLL Mini Onebody ImplantLL Temporary CapLW Abutment ScrewLW Angled AbutmentLW Cover ScrewLW Healing AbutmentLW ImplantLW Implant SLALW Implant System 23 moreLW Implant System AbutmentLW Narrow Abutment ScrewLW Narrow Angled AbutmentLW Narrow Cover ScrewLW Narrow Healing AbutmentLW Narrow ImplantLW Narrow Implant SLALW Narrow Implant SystemLW Narrow Pre-milled AbutmentLW Narrow Solid AbutmentLW Narrow Solid Abutment SETLW Narrow Temporary AbutmentLW Narrow UCLA AbutmentLW Narrow Vis AbutmentLW Narrow Vis Abutment SETLW Pre-milled AbutmentLW Retraction CapLW Solid AbutmentLW Solid Abutment SETLW Temporary AbutmentLW UCLA AbutmentLW Vis AbutmentLW Vis Abutment SET | 2023 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | LL Implant SystemLL Mini Onebody ImplantLL Temporary CapLW Abutment ScrewLW Angled AbutmentLW Cover ScrewLW Healing AbutmentLW ImplantLW Implant SLALW Implant System 16 moreLW Narrow Abutment ScrewLW Narrow Angled AbutmentLW Narrow Cover ScrewLW Narrow Healing AbutmentLW Narrow ImplantLW Narrow Implant SLALW Narrow Implant SystemLW Narrow Solid AbutmentLW Narrow Solid Abutment SETLW Narrow Temporary AbutmentLW Narrow UCLA AbutmentLW Narrow Vis AbutmentLW Narrow Vis Abutment SETLW Solid AbutmentLW Temporary AbutmentLW Vis Abutment | 2023 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | Bone Profile DrillCortical DrillCortical Drill S2Crestal DrillDiamond Reamer DrillGuide DrillGuide Full Anchor Twist DrillGuide Full Cortical DrillGuide Full Flattening DrillGuide Full Lindemann Drill 19 moreGuide Full lnitial DrillGuide Full Step DrillGuide Full Twist DrillHarvesting DrillLC Counter Sinking DrillLindemann DrillPath DrillPoint DrillRound DrillSaw DiscShort Cortical DrillShort Step DrillShort Twist DrillStep DrillStopper Point DrillStraight Round BurTrimming DrillTwist DrillTwist Drill S2 | 2023 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | OV Dental Mallet | 2023 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Maker | Depth Gauge | 2023 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | Handle for tips | 2023 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Maker | OV Freer Elevator | 2023 |
| Dental Surgical CuretteEMK · Class 1 | Dental hand instruments | Maker | OV Sinus Curette | 2023 |
| Surgical Bone ChiselEML · Class 1 | Dental hand instruments | Maker | OV Chisel | 2023 |
| Surgical Osteotome ChiselEMM · Class 1 | Dental hand instruments | Maker | Convex Osteotome | 2023 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Bone Profile Guide PinBone Splitter 1Bone Splitter 2Bone Tack CarrierDrill ExtensionDrill StopperDrill Stopper S2Guide Full Anchor Driver EngineGuide Full Anchor Driver Short WrenchGuide Full Anchor Pin 59 moreGuide Full NoMount Driver EngineGuide Full NoMount Driver WrenchImplant Path PinLC Implant Path PinLC NoMount Driver EngineLC NoMount Driver WrenchLC Pick-up Impression CopingLC Pick-up Impression Coping Guide PinLC Solid Abutment Plastic Impression CopingLC Solid Plus Abutment Plastic Impression CopingLC Transfer Impression CopingLC Transfer Impression Coping Guide PinLL Driver SeparatorLL Implant Driver EngineLL Implant Driver WrenchLL Lab AnalogLL Plastic Impression CopingLL Scan BodyLW Digital Lab Analog GMLW Lab AnalogLW MountLW Mount ScrewLW Narrow Dirigal Lab Analog GMLW Narrow Lab AnalogLW Narrow Pick-up Impression CopingLW Narrow Pick-up Impression Coping Guide PinLW Narrow Scan BodyLW Narrow Scan Body ScrewLW Narrow Transfer Impression CopingLW Narrow Transfer Impression Coping Guide PinLW Oss Abutment Clearance Gap GaugeLW Oss Abutment Driver EngineLW Oss Abutment Driver WrenchLW Oss Abutment Pick-up Impression CopingLW Oss Abutment Pick-up Impression Coping Guide PinLW Oss Abutment Scan BodyLW Oss Abutment Scan Body ScrewLW Oss Abutment Transfer Impression CopingLW Oss Abutment Transfer Impression Coping Guide PinLW Oss Slot DriverLW Pick-up Impression CopingLW Pick-up Impression Coping Guide PinLW Plastic Impression CopingLW Scan BodyLW Scan Body ScrewLW Scan Body SETLW Solid Lab AnalogLW Transfer Impression CopingLW Transfer Impression Coping Guide PinNoMount Driver EngineNoMount Driver WrenchParallel PinScrew Remover TipSinus Drill StopperTorque WrenchWrench1.2 Ball HEX Driver Wrench1.2 Hex Driver Engine1.2 Hex Driver Wrench | 2022 |
| Dental Implant Surgical TrayOFY · Class 1 | Implant instruments & surgical kits | Maker | Lili Guide KitLilivis Guide Full KitSinus & GBR KitSurgical Master KitSurgical Master Kit2Surgical Option KitSurgical Simple KitSurgical Simple Kit 2Surgical Simple Kit 3 | 2023 |
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 Ossvis Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 5 Dec 2024 | K242703 | LW Pre-milled Abutment | NHA Endosseous Dental Implant Abutment |
| 7 Nov 2024 | K242379 | LL Implant System | DZE Root-Form Endosseous Implant |
| 31 Jul 2024 | K233808 | LW Narrow Implant System | DZE Root-Form Endosseous Implant |
| 25 Mar 2024 | K233167 | LW Implant System Abutment | NHA Endosseous Dental Implant Abutment |
| 15 Sep 2023 | K231235 | LW UCLA Abutment | NHA Endosseous Dental Implant Abutment |
| 14 Sep 2023 | K231079 | LW Retraction Cap | NHA Endosseous Dental Implant Abutment |
| 8 Aug 2023 | K223924 | LW Implant System | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| OSSVIS CO., LTD.FDA reg. 3025338240 | Anyang-si Gyeonggi, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10086315). 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.