Manufacturer registered with FDA
WARANTEC Co., Ltd.
Sungnam-si, South Korea. Lists 4 dental device types with FDA across 1 registered establishment, and holds 4 510(k) clearances as applicant.
- Device types listed
- 4
- Brands and models
- 1,826
- 510(k) clearances
- 42009–2023
- Markets registered in
- 511 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2000–2026
Registered in 5 markets
Where regulators' registries name WARANTEC 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 | WARANTEC Co., Ltd. | 4 clearances | 2009–2023 | Below |
| China | NMPA | Registration holder | 韩国沃兰牙科器械有限公司WARANTEC CO., Ltd.韩国沃兰牙科器械有限公司 WARANTEC CO., Ltd. | 4 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | WARANTEC CO., LTD.WARANTEC Co., Ltd. · WARANTEC Co.,Ltd. | 4 | 2011–2026 | Pure Global AI |
| Egypt | EDA | Manufacturer | Warantec Co., Ltd, | 2 | 2026–2026 | Pure Global AI |
| Japan | PMDA | Registration holder | ＷＡＲＡＮＴＥＣ Ｃｏ．， Ｌｔｄ． | 1 | 2022–2022 | 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 WARANTEC 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 | FIU36085FIU36100FIU36115FIU36130FIU40070FIU40085FIU40100FIU40115FIU40130FIU45070 412 moreFIU45085FIU45100FIU45115FIU45130FIU50070FIU50085FIU50100FIU50115FIU50130FIU55070FIU55085FIU55100FIU55115FIU55130FIU60070FIU60085FIU60100FUT43070FUT43085FUT43100FUT43115FUT43130FUT48070FUT48085FUT48100FUT48115FUT48130FUT53070FUT53085FUT53100FUT53115FUT53130FUT63070FUT63085FUT63100FUT63115I0UTA3814AI0UTA3814HAI0UTA3816AI0UTA3816HAI0UTA3824AI0UTA3824HAI0UTA3826AI0UTA3826HAI0UTA3834AI0UTA3834HAI0UTA3836AI0UTA3836HAI0UTA3844AI0UTA3844HAI0UTA3846AI0UTA3846HAI0UTA3854AI0UTA3854HAI0UTA3856AI0UTA3856HAI0UTA3864AI0UTA3864HAI0UTA3866AI0UTA3866HAI0UTA4514I0UTA4514HI0UTA4516I0UTA4516HI0UTA4524I0UTA4524HI0UTA4526I0UTA4526HI0UTA4534I0UTA4534HI0UTA4536I0UTA4536HI0UTA4544I0UTA4544HI0UTA4546I0UTA4546HI0UTA4554I0UTA4554HI0UTA4556I0UTA4556HI0UTA4564I0UTA4564HI0UTA4566I0UTA4566HI0UTA5514I0UTA5514HI0UTA5516I0UTA5516HI0UTA5524I0UTA5524HI0UTA5526I0UTA5526HI0UTA5534I0UTA5534HI0UTA5536I0UTA5536HI0UTA5544I0UTA5544HI0UTA5546I0UTA5546HI0UTA5554I0UTA5554HI0UTA5556I0UTA5556HI0UTA5564I0UTA5564HI0UTA5566I0UTA5566HIUAA1526HIUAA1526HAIUAA1528HIUAA1528HAIUAA1536HIUAA1536HAIUAA1538HIUAA1538HAIUAA1546HIUAA1546HAIUAA1548HIUAA1548HAIUAA4020HIUAA4020HAIUAA4030HIUAA4030HAIUAA4040HIUAA4040HAIUAA5020HIUAA5030HIUAA5040HIUASLIUASLAIUASSIUASSAIUBA4010AIUBA4020AIUBA4030AIUBA4040AIUBA4050AIUBA4060AIUBA5010 | 2018 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | CD-38CD-43CD-53CRD-N8.5CRD-R10CRD-R11.5CRD-R13CRD-R8.5CRD-W10CRD-W11.5 867 moreCRD-W13CRD-W8.5DEDPEWFHS33085FHS33100FHS33115FHS33130FHS33150FHS43085FHS43100FHS43115FHS43130FHS43150FHS53085FHS53100FHS53115FHS53130FHS53150FHT33085FHT33100FHT33115FHT33130FHT43085FHT43100FHT43115FHT43130FHT53085FHT53100FHT53115FHT53130FHUT33085FHUT33085BFHUT33100FHUT33100BFHUT33115FHUT33115BFHUT33130FHUT33130BFHUT43085FHUT43085BFHUT43100FHUT43100BFHUT43115FHUT43115BFHUT43130FHUT43130BFHUT53085FHUT53085BFHUT53100FHUT53100BFHUT53115FHUT53115BFHUT53130FHUT53130BFIS36085FIS36100FIS36115FIS36130FIS36150FIS41085FIS41100FIS41115FIS41130FIS41150FIS51085FIS51100FIS51115FIS51130FIS51150FIT43085FIT43100FIT43115FIT43130FIT53085FIT53100FIT53115FIT53130FIU36085FIU36100FIU36115FIU36130FIU40070FIU40085FIU40100FIU40115FIU40130FIU45070FIU45085FIU45100FIU45115FIU45130FIU50070FIU50085FIU50100FIU50115FIU50130FIU55070FIU55085FIU55100FIU55115FIU55130FIU60070FIU60085FIU60100FUT43070FUT43085FUT43100FUT43115FUT43130FUT48070FUT48085FUT48100FUT48115FUT48130FUT53070FUT53085FUT53100FUT53115FUT53130FUT63070FUT63085FUT63100FUT63115GPAGPSH0AA3324DH0AA3334DH0AA3336DH0AA3338DH0AA3346DH0AA3348DH0AA3356DH0AA3358DH0AA4324DH0AA4334DH0AA4336DH0AA4338DH0AA4346D | 2011 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | AD-32AD-38BP-45BP-55BP-75CD-70CRD33085D20-LD20-SDAR-28 189 moreDCR-70GBFGBF090GBF105GBF120GLADGLD28GPD-35GPD-40GPD-45GPD-50GPD-55GPD-60GSD30085GSD30100GSD30115GSD30130GSD30145GSD35085GSD35100GSD35115GSD35130GSD35145GSD40085GSD40100GSD40115GSD40130GSD40145GSD45085GSD45100GSD45115GSD45130GSD45145GSD50085GSD50100GSD50115GSD50130GSD50145GSD55085GSD55100GSD55115GSD55130GTPIUCD-36IUCD-40IUCD-45IUCD-50IUCD-55IUCD-60IUSD30070IUSD30085IUSD30100IUSD30115IUSD30130IUSD35070IUSD35085IUSD35100IUSD35115IUSD35130IUSD40070IUSD40085IUSD40100IUSD40115IUSD40130IUSD45070IUSD45085IUSD45100IUSD45115IUSD45130IUSD50070IUSD50085IUSD50100IUSD50115IUSD50130IUSD55070IUSD55085IUSD55100LD-20-LLD-20-SNLD-20NPD-33NSD-27OSD-32OSD-32TPDPD-18PD-23PD-30PD-35PD-40PD-45PD-50PD-55PD-60PD-LSD-20-LSD-20-SSD-30-LSD-30-SSD-35-LSD-35-SSD-40-LSD-40-SSD-45-LSD-45-SSD-50-LSD-50-SSD-55-LSD-55-SSD33085SD33130SD36070SD36085SD36100SD36115SD36130SD38070SD38085SD38100SD38115SD38130SD43070SD43085SD43100SD43115SD43130SD48070SD48085SD48100SD48115SD48130SD53070SD53085SD53100SD53115SD53130SD63070SD63085SD63100SDR-80T | 2021 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | AD-STADRALT-28ALT-33AQUA-HAAST-30AT-02BP-35BP-35CDG-01 318 moreDLDPDSDS-10DS-11.5DS-13DS-5DS-5.5DS-6DS-7DS-8.5DSW-10DSW-11.5DSW-13DSW-5DSW-5.5DSW-7DSW-8.5ESP KITESP-EG16ESP-EG18ESP-HESP-S1610ESP-S1615ESP-S1620ESP-S1625ESP-S1810ESP-S1815ESP-S1820ESP-S1825ESP-S1830FR-50LFR-50SFR-55LFR-55SFR-60LFR-60SFR-65LFR-65SFR-75LFR-75SFR-ITFR-IUGAD-HGAD-RGFD-HMGFD-HSGFD-RM120GFD-RS090GFD-RS105GHRSGHRWGLAPGLASGPCGPSGVA090SGVA090WGVA105SGVA105WGVA120MGVA120WHA-HHHA-HHAHA-THHA-TNHA-TRHA-TWHD-IU-MLHD-IU-MSHD-IU-NMLHD-IU-NMSHD-IU-NRLHD-IU-NRSHD-IU-RLHD-IU-RSHD-LT-LHD-LT-LLHD-LT-SHD-MGHD-MG-LHD-SR-08HD-SR-12HD-SR-CMHD-TW-BHD-TW-LHD-TW-LLHD-TW-SHG-SR-NHG-SR-RHG-SR-WI0MUPCHI0MUPCNI0SCTEI0SCTELIC0AN43IC0AN53IC0GHCIC0GHCAIC0IPP43LIC0IPP43SIC0IPT40EIC0IPT40LIC0MAN40HIC0MAN43IC0MAN43HIC0MIPP43IC0MIPP43HIC0MUPC40IC0MUPC50IC0MUPP40IC0MUPP40HIC0MUPT40LIC0MUPT40SIC0MUPT40SSIC0MUPT43LIC0MUPT43SIC0MUPT43SSIC0MUPTLIC0MUPTSIC0MUPTSSIC0SAN50HIG-AR-RIG-AR-WIG-SR-NOIG-SR-OIS0IPPLIS0IPPLLIS0IPPSIS0IPTLIS0IPTSIS0MIPPLIS0MIPPLLIS0MIPPSIS0MUPT40LIS0MUPT40SIS0MUPT40SSIS0MUPTLIS0MUPTSIS0MUPTSS | 2021 |
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 WARANTEC Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 2 Oct 2023 | K221972 | Warantec Custom Abutment | NHA Endosseous Dental Implant Abutment |
| 12 May 2023 | K221969 | IU Implant System Abutment | NHA Endosseous Dental Implant Abutment |
| 18 Jun 2018 | K172345 | IU Implant System | DZE Root-Form Endosseous Implant |
| 27 Mar 2009 | K081748 | ONEPLANT DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| WARANTEC Co., Ltd.FDA reg. 3009514134 | Seongnam-si Gyeonggi, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10039281). 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.