Manufacturer registered with FDA
Dentis Co., Ltd.
Daegu, South Korea. Lists 15 dental device types with FDA across 4 registered establishments, and holds 37 510(k) clearances as applicant.
- Device types listed
- 15
- Brands and models
- 529
- 510(k) clearances
- 372008–2026
- Markets registered in
- 11116 registrations outside the US
- Establishments
- 4South Korea
510(k) clearances per year, 2000–2026
Registered in 11 markets
Where regulators' registries name Dentis 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 | Dentis Co., Ltd. | 37 clearances | 2008–2026 | Below |
| Costa Rica | Ministerio de Salud | Manufacturer | DENTIS CO., LTDDENTIS CO.,Ltd · DENTIS Co Ltd · +2 | 30 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Dentis Co Ltd | 28 | 2012–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | DENTIS CO., LTD | 22 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Dentis Co., Ltd.DENTIS CO., LTD. · DENTIS CO., LTD | 15 | 2009–2025 | Pure Global AI |
| China | NMPA | Registration holder | 登特司有限公司Dentis Co., Ltd.登特司有限公司DENTIS. Co., LTD. · DENTIS MEDICAL DIVISION 登特司医疗有限公司 · +1 | 8 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | DENTIS CO., LTD. | 6 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | DENTIS MEDICAL DIVISIONDENTIS CO., LTD | 3 | — | Pure Global AI |
| Japan | PMDA | Registration holder | Ｄｅｎｔｉｓ Ｃｏ．， Ｌｔｄ． | 2 | 2025–2025 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | DENTIS CO, LTD | 1 | 2019–2019 | Pure Global AI |
| Egypt | EDA | Manufacturer | DENTIS Co., Ltd, | 1 | 2026–2026 | 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 Dentis 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 | Dentis Dental Implant SystemDentis i-Clean SystemDentis I-FIX AbutmentDentis s-Clean Abutment MiniDentis s-Clean Regular AbutmentDentis s-Clean s-LineDentis s-Clean s-Line MiniDentis s-Clean SQ-SL Narrow Implant SystemHaptite Coating Implant SystemMU System 10 mores-Clean Link Abutments-Clean Link Abutment Narrows-Clean OneQ-SL Narrow Implant Systems-Clean Pre-Milled Abutments-Clean Pre-Milled Abutment Minis-Clean ScanHealing Abutments-Clean SQ-SL Implant System Minis-Clean SQ-SL Implant System Regulars-Clean TiN Coating AbutmentsSAVE GBR | 2012 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | DENTIS DENTAL IMPLANT SYSTEMDentis s-Clean s-LineDentis s-Clean s-Line MiniDentis s-Clean SQ-SL FixtureDentis SQ-SL AXEL FixtureHaptite Coating Implant SystemI-Fix SystemOneQ-SL Implant SystemOneQ-SL s-Clean Implant Systems-Clean OneQ-SL Narrow Implant System 2 mores-Clean SQ-SL Implant System Minis-Clean SQ-SL Implant System Regular | 2008 |
| Operative Dental UnitEIA · Class 1 | Dental chairs & operative units | Maker | Luvis Chair (LC700C) | 2024 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Maker | ChecQ (AC100) | 2025 |
| Dental Chair with Operative UnitKLC · Class 1 | Dental chairs & operative units | Maker | Luvis Chair (LC700C) | 2024 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Aqua Tip (DSSAT, DSSAT31, DSSAT41)AXEL AOX KIT (DSAAONK, DSAAOMK)BMS Chisel (DSCL-05)Bone Chip (DGBC50)Bone packer (DSSBP, DSSBPN)Bone packer (DTOCA-BP)Bone Profiler (DBP45, DBP55, DBP65)Bone Profiler Base (DBPBM, DBPBR, DBPBN)BONE PROFILER KIT (DBPK)Bone pusher (DNLBC-BP) 467 moreBone Ridge Chisel (DBCA15, DBCA25)Bone Screw Driver (DGBSD)Bone Screw Driver Tip for Hand Piece (DGBSDTH)Bone syringe (DBS-01)Bone Tack Drill (DBTD08)Bone Tack Driver Curved (DGBTDC)Bone Tack Driver Straight (DGBTDS)Bone Tack Removal Tip (DGBTRT)Bone Trimming Bur (DGBTB50L, DGBTB50H)Bone Well (DSSBW)Carbide Bur (DSSCB14L, DSSCB18L)Combined KIT (DCK, DGCK)Cortical Perforation bur (DGCPB10L, DGCPB10H)Crestal Stopper (DSSCS3, DSSCS4, DSSCS5, DSSCS6, DSSCS7, DSSCS3N, DSSCS4N, DSSCS5N, DSSCS6N, DSSCS7N, DSSCS8N)Crestal Stopper (DSSCS8, DSSCS9, DSSCS10, DSSCS11, DSSCS12)DENTIS GUIDE Anchor Screw (DGAS18)DENTIS GUIDE Anchor Twist Drill (DGATD)Depth Gauge (DDG22, DDG28)Depth Gauge (DGAG-08, DSSDGN)Depth Gauge (DSSDG)Diamond Bur (DSSDB20L)Diamond reamer (DTOCA-DR20, DTOCA-DR28, DTOCA-DR33)Digital Lab Analog Screw (DDLAWS)DOS KIT (DOSK)Drill (DNLBC-2, DNLBC-3, DNLBC-4, DNLBC-5)Drill Extension (DDE)Drill Holder (DDH39, DDH43, DDH53, DDH53L)Drilling Guide Wheel (DGW6, DGW7, DGW8, DGW9, DGW10, DGW12)e-Clean Fixture Lab Analog (DELAM, DELAR, DELAW)e-Clean Fixture Mount (DEFMM, DEFMR, DEFMW)e-Clean Fixture Short Mount (DEFMSM, DEFMSR, DEFMSW)e-Clean Fixture Short Mount Screw (DESMS, DESRS, DESWS)e-Clean Pick-Up Impression Coping (DEIM40HS, DEIR50HS, DEIR60HS, DEIW60HS, DEIM40NS, DEIR50NS, DEIR60NS, DEIW60NS)e-Clean Pick-Up Impression Coping Guide Pin (DEGPM10, DEGPM15, DEGPM20)e-Clean Pick-Up Impression Coping Guide Pin (DEGPR10, DEGPR15, DEGPR20, DEGPW10, DEGPW15, DEGPW20)e-Clean Plastic UCLA Abutment (DEPMH, DEPMN, DEPRH, DEPRN, DEPWH, DEPWN)e-Clean tapered KIT (DEK, DGEK)e-Clean Transfer Impression Coping (DETIM40NS, DETIM40HS, DETIR50NS, DETIR50HS)e-Clean Transfer Impression Coping (DETIR60NS, DETIR60HS, DETIW60NS, DETIW60HS)e-Clean Transfer Impression Guide Pin (DETSM, DETSR, DETSW)Expander drill (DSDEXP-01, DSDEXP-02, DSDEXP-03, DSDEXP-04, DSDEXP-05)Expander drill (DSDEXPM-02, DSDEXPM-03, DSDEXPM-04, DSDEXPM-05)GT SMART KIT (DGNSK, DGENSK)Guide Anchor Pin (DGAP14)Guide Bone Anchor (DGBA09, DGBA11, DGBA13)Guide Drill (DGD-20)Guide Drill (DSDGDL-02)Guide Fixture Anchor (DGFAR09, DGFAM09, DGFAN09, DGFAR11, DGFAM11, DGFAN11, DGFAR13, DGFAM13, DGFAN13)Guide Punch (DSDGTS-40, DSDGTS-50)Guide Wheel Drill (DGWPDS, DGWPDL)Guide Wheel Guide Pin (DGWGP6, DGWGP7, DGWGP8, DGWGP9, DGWGP10, DGWGP12)Guide Wheel Guide Pole (DGWGP, DGWGPL)Guide Wheel Initial Drill (DGWID20)Guide Wheel KIT (DGWK)Handpiece condenser (DSDADP-01)Hex Driver for Machine (DMDH125L, DMDH125S, DMDH12S)Hex Driver for Ratchet (DRD09, DRD12S, DRD12L, DRD125S, DRD125L, DRHDL09, DRHDS125, DRHDL125)Hex Driver for Ratchet (DRHDES125, DRHD3512)Hex Driver for Ratchet (DRHDL12)Hex Driver for Ratchet (DRHDS12, DRHD2312, DRHD23125, DRHD35125)Hex Driver for Ratchet (DRHDSO, DRHDLO)i-Clean Digital Lab Analog (DIDLAR, DIDLARS, DIDLAW, DIDLAWS)i-Clean Excellent Abutment Driver (DESAD)i-Clean Excellent Solid Abutment Lab Analog (DIESLA30, DIESLA40, DIESLA55, DIESLA70)i-Clean Excellent Solid Impression Cap (DIESICR, DIESICW)i-Clean Excellent Solid Positioning Cylinder (DIESIPCR, DIESIPCW)i-Clean Fixture Lab Analog (DILA, DILAW)i-Clean Guide No Mount Driver (DIGNMS, DIGNML, DIGNRS, DIGNRL)i-Clean Neck Profiler (DINP48, DINP65)i-Clean No-mount Driver (DINDS, DINDL, DMMDI)i-Clean Octa Pick-Up Impression Coping (DIOINS, DIOIWNS, DIOIOS, DIOIWOS)i-Clean Octa Pick-Up Impression Coping Guide Pin (DIOGP, DIOGP10, DIOGP15, DIOGP20)i-Clean Octa Transfer Impression Coping (DIOTIS, DIOTIWNS, DIOTIOS, DIOTIWOS)i-Clean OneQ KIT (DIOK)i-Clean OneQ KIT (DIOKU)i-Clean Pick-Up Impression Coping (DIPINS, DIPIRS, DIPIS60S, DIPIWS, DIPIWNS)i-Clean Plastic Cylinder (DIOPN, DIOPO)i-Clean Plastic Cylinder (DIOPWO, DIOPWN)i-Clean Ratchet Driver (DRMDIS, DRMDIL)i-Clean SAVE Fixture Lab Analog (DILAS)i-Clean ScanBody (DISBS, DISBL, DISBWS, DISBWL)i-Clean ScanBody (DISBSS, DISBLS, DISBWSS, DISBWLS)i-Clean Shoulder Analog (DIISAR, DIISAW65)i-Clean Shoulder Analog Pin (DISAPR)i-Clean Solid Abutment Driver (DSAD, DSADS, DSADL)i-Clean Solid Abutment Lab Analog (DISLA30, DISLA40, DISLA55, DISLA70)i-Clean Solid Abutment Lab Analog (DISLAW40, DISLAW55, DISLAW70)i-Clean Solid Abutment Plastic Coping (DISPB, DISWPB, DISPS, DISWPS)i-Clean Solid Impression Cap (DISICR, DISICW, DISICW65i-Clean Solid Positioning Cylinder (DISIPCR, DISIPCW, DISIPCW65)i-Clean Solid Type PS Abutment (DPIS40, DPIS55, DPIS70, DPIA15, DPIA25)i-Clean Transfer Impression Coping (DITIRS, DITIWS, DITINS, DITIWNS)i-Clean Transfer Impression Guide Pin (DITL, DITS)I-FIX Angled Mount Adapter (DNAMB, DNAMS, DNAMA)I-FIX Angled Type Impression Coping (DMIC12S, DMIC18S, DMIC23S)I-FIX Angled Type Lab Analog (DMAL)I-FIX Angled Type Mount Adapter (DMAMA)I-FIX Angled Type Mount Adapter Screw (DMAMS)I-FIX Angled Type ScanBody (DFASBLS, DFASBSS, DFASBL, DFASBS)I-FIX Angled Type ScanBody Screw (DFSBS)I-FIX Bone Profiler (DBPI40)I-FIX Fixture Machine Driver (DMML, DMMS)I-FIX Fixture Ratchet Driver (DMRL, DMRS)I-FIX O-Ring Type Lab Analog (DMOL)I-FIX Point Drill (DIPD)I-FIX Post Type Impression Cap (DMPIC)I-FIX Post Type Lab Analog (DMPL)I-FIX Post Type Temporary Cap (DMPTC)i, s-Clean tapered KIT (DIK, DGIK, DIKO)Impression Coping Guide Pin (DSGPZS15, DSGPZS19, DSGPZ15, DSGPZ19)Impression Coping Guide Pin (DSTSSZ, DSTSLZ, DSTSZ, DSTLZ)Lateral Approach Cutter (DLAC-6, DLAC-8)Lateral Approach Drill (DLAD-6, DLAD-8)Lateral Approach Drill (DSSLAD60, DSSLAD80)Lateral Approach Reamer (DLAR-R8, DLAR-F8)Lateral Approach Reamer (DSSAR60, DSSAR80)Lateral Stopper (DSSLS05, DSSLS10, DSSLS15, DSSLS20, DSSLS25, DSSLS30)Lindemann Drill (DLIND23S, DLIND23L, DSSLD20, DLD-2, DSSLD20N)Marking drill (DMD-3)Mini Depth Gauge (DMDP)Mini KIT (DMK)Mini Twist Drill (DMD13, DMD18, DMD23)Mini Twist Drill (DMD13TC, DMD18TC, DMD23TC)Mount Driver for Machine (DMHD24, DMHD30, DMHDS24)Mount Driver for Ratchet (DRHDS24, DRHDL24, DRHDS30, DRHDL30)MU Abutment Driver (DMAD)MU Gingival ScanBody (DSMUGSBF)MU Lab Analog (DMLA)MU Pick-Up Impression Coping (DMPUICS)MU Plastic Cylinder (DMPCS)MU Polishing Protector (DMPP)MU Reverse ScanBody (DSMURSBS, DSMURSB)MU Reverse Screw (DSMURS)MU ScanBody Screw (DSMUSS)MU Transfer Impression Coping (DMTICS)O-Ring Abutment Driver (DORADS, DORADL)O-Ring Abutment Lab Analog (DOLA)O-Ring Abutment O-Ring (DOAO100)Octa Abutment Driver (DOADS, DOADL)Octa Abutment Lab Analog (DIOLA, DIOLAW) | 2009 |
| Dental Chair without Operative UnitNRU · Class 1 | Dental chairs & operative units | Maker | Luvis Chair (LC700C-chair only plus)Luvis Chair (LC700C-chair only) | 2024 |
| Powered Bone DrillDZI · Class 2 | Surgical drills & motors | Lister | Silfradent SRL | 2014 |
| Intraosseous Fixation ScrewDZL · Class 2 | Maxillofacial plates & screws | Maker | SAVE GBR | 2023 |
| Dental Operating LightEAZ · Class 1 | Dental operating lights | Maker | LUVIS-C100 SeriesLUVIS-C200 SeriesLUVIS-C300 SeriesLUVIS-C400 SeriesLUVIS-C500 SeriesLUVIS-C600 SeriesLUVIS-C700 SeriesMedical LED Light (Luvis S) | 2012 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | ZMD-1000B TEMPORARY | 2019 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | ZMD-1000B TRAY | 2016 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Maker | LED Mouth Prop | 2010 |
| Cartridge SyringeEJI · Class 2 | Dental needles & syringes | Maker | DENOPS | 2021 |
| Sequential AlignerNXC · Class 2 | Clear aligners | Maker | Mesheet | 2024 |
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 Dentis Co., Ltd. as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 4 Mar 2026 | K253493 | Dentis SQ-SL AXEL Fixture | DZE Root-Form Endosseous Implant |
| 21 Mar 2025 | K241065 | ChecQ (AC100) | EKX Ac-Powered Direct Drive Handpiece |
| 6 Sep 2024 | K233921 | Luvis Chair (LC700C) | KLC Dental Chair with Operative Unit |
| 25 Jul 2024 | K241063 | s-Clean ScanHealing Abutment | NHA Endosseous Dental Implant Abutment |
| 20 May 2024 | K240511 | Dentis s-Clean SQ-SL Fixture | DZE Root-Form Endosseous Implant |
| 22 Feb 2024 | K233544 | MESHEET | NXC Sequential Aligner |
| 4 Aug 2023 | K230126 | Dentis s-Clean Regular Abutment | NHA Endosseous Dental Implant Abutment |
| 11 Jul 2023 | K230307 | Dentis i-Clean System | NHA Endosseous Dental Implant Abutment |
| 25 May 2023 | K230246 | Dentis s-Clean SQ-SL Narrow Implant System | NHA Endosseous Dental Implant Abutment |
| 24 May 2023 | K230523 | s-Clean Link Abutment Narrow | NHA Endosseous Dental Implant Abutment |
| 3 May 2023 | K230203 | Dentis I-FIX Abutment | NHA Endosseous Dental Implant Abutment |
| 23 Mar 2023 | K222367 | SAVE GBR | DZL Intraosseous Fixation Screw |
| 7 Feb 2023 | K222451 | SAVE GBR | NHA Endosseous Dental Implant Abutment |
| 13 Jan 2023 | K222913 | s-Clean Link Abutment | NHA Endosseous Dental Implant Abutment |
| 12 Jan 2023 | K222976 | MU System | NHA Endosseous Dental Implant Abutment |
| 16 Jun 2022 | K220440 | Dentis s-Clean Abutment Mini | NHA Endosseous Dental Implant Abutment |
| 10 Sep 2021 | K210410 | s-Clean Pre-Milled Abutment Mini | NHA Endosseous Dental Implant Abutment |
| 19 Aug 2021 | K210362 | s-Clean Pre-Milled Abutment | NHA Endosseous Dental Implant Abutment |
| 4 Jun 2021 | K210080 | Dentis s-Clean s-Line Mini | DZE Root-Form Endosseous Implant |
| 19 Apr 2021 | K210134 | Dentis s-Clean s-Line | DZE Root-Form Endosseous Implant |
| 18 Mar 2021 | K202773 | s-Clean SQ-SL Implant System Mini | DZE Root-Form Endosseous Implant |
| 17 Feb 2021 | K210132 | s-Clean SQ-SL Implant System Regular | DZE Root-Form Endosseous Implant |
| 13 Apr 2020 | K200099 | s-Clean SQ-SL Implant System Mini | DZE Root-Form Endosseous Implant |
| 4 Feb 2020 | K192688 | s-Clean SQ-SL Implant System Regular | DZE Root-Form Endosseous Implant |
| 7 Dec 2018 | K180657 | Resin for Temporary Crown & Bridge | EBG Resin Temporary Crown and Bridge |
| 29 Nov 2017 | K171694 | s-Clean TiN Coating Abutments | NHA Endosseous Dental Implant Abutment |
| 6 Sep 2017 | K171027 | Dentis Dental Implant System | DZE Root-Form Endosseous Implant |
| 27 Apr 2017 | K170220 | OneQ-SL s-Clean Implant System | DZE Root-Form Endosseous Implant |
| 7 Dec 2016 | K161244 | s-Clean OneQ-SL Narrow Implant System | DZE Root-Form Endosseous Implant |
| 21 Jun 2016 | K160213 | s-Clean Tapered II RBM Implant System | DZE Root-Form Endosseous Implant |
| 8 Apr 2016 | K153639 | OneQ-SL s-Clean Implant System | DZE Root-Form Endosseous Implant |
| 10 Dec 2015 | K142313 | OneQ-SL Implant System | DZE Root-Form Endosseous Implant |
| 24 Jul 2015 | K150344 | Dentis Dental Implant System | DZE Root-Form Endosseous Implant |
| 1 Feb 2012 | K111364 | HAPTITE COATING IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 19 Jun 2009 | K082843 | MODIFICATON TO: DENTIS DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 29 Apr 2009 | K083586 | I-FIX SYSTEM | DZE Root-Form Endosseous Implant |
| 4 Apr 2008 | K073486 | DENTIS DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
Some of these clearances are listed with FDA today by another company: Digital Age Dental Laboratories, Ltd. (1).
Also lists devices cleared under other names
Dentis Co., Ltd. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Silfradent srl (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 1 Apr 2009 | K083569 | SURGYBONE | Silfradent srl | DZI Powered Bone Drill |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DENTIS CO., LTD.FDA reg. 3007031098 | Daegu, South Korea | Foreign exporter, Manufacturer |
| Dentis Co.,LtdFDA reg. 3036190511 | Dong-gu Daegu, South Korea | Manufacturer |
| DENTIS MEDICAL DIVISIONFDA reg. 3033509587 | Dong-gu Daegu, South Korea | Manufacturer |
| DENTIS MEDICAL DIVISIONFDA reg. 3010373494 | Daegu, South Korea | Manufacturer |
Other names on FDA records
Dentis Medical Division
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10025697). 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.