Manufacturer registered with FDA
Ze Fang Technology Co., Ltd.
Taichung, Taiwan. Lists 8 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 8
- Brands and models
- 1,003
- 510(k) clearances
- 12022–2022
- Markets registered in
- 346 registrations outside the US
- Establishments
- 1Taiwan
510(k) clearances per year, 2007–2026
Registered in 3 markets
Where regulators' registries name Ze Fang Technology Co., Ltd. as the manufacturer or the registration holder of a device.
RegisteredHome: TaiwanOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Ze Fang Technology Co., Ltd. | 1 clearances | 2022–2022 | Below |
| European Union | EUDAMED | Manufacturer | Ze Fang Technology Co., Ltd. | 45 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | ZE FANG TECHNOLOGY CO., LTD | 1 | — | 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 Ze Fang Technology 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 |
|---|---|---|---|---|
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | Kobayashi Pre-cut Ligature Ties-012Kobayashi Stainless Steel Ligature Ties-012Kobayashi Stainless Steel Ligature Ties-014New Cu-Niti13 Universal FormNew Cu-Niti14 Universal FormNew Cu-Niti14x25 UniversalNew Cu-Niti16 Universal FormNew Cu-Niti16x25 UniversalNew Cu-Niti18 Universal FormNew Cu-Niti18x25 Universal 138 moreNew Cu-Niti19x25UniversalNew Cu-Niti20 Universal FormNew Cu-Niti21x25 UniversalNiti Archwire-Lower-12Niti Archwire-Lower-14Niti Archwire-Lower-16Niti Archwire-Lower-16*16Niti Archwire-Lower-16*22Niti Archwire-Lower-17*22Niti Archwire-Lower-17*25Niti Archwire-Lower-18Niti Archwire-Lower-18*25Niti Archwire-Lower-19*25Niti Archwire-Lower-20Niti Archwire-Upper-12Niti Archwire-Upper-14Niti Archwire-Upper-16Niti Archwire-Upper-16*16Niti Archwire-Upper-16*22Niti Archwire-Upper-17*22Niti Archwire-Upper-17*25Niti Archwire-Upper-18Niti Archwire-Upper-18*25Niti Archwire-Upper-19*25Niti Archwire-Upper-20NITI Orthodontic Wire-NT001200NITI Orthodontic Wire-NT001200CUNITI Orthodontic Wire-NT001400NITI Orthodontic Wire-NT001400CUNITI Orthodontic Wire-NT001600NITI Orthodontic Wire-NT001600CUNITI Orthodontic Wire-NT001800NITI Orthodontic Wire-NT001800CUNITI Orthodontic Wire-NT101200NITI Orthodontic Wire-NT101200CUNITI Orthodontic Wire-NT101400NITI Orthodontic Wire-NT101400CUNITI Orthodontic Wire-NT101600NITI Orthodontic Wire-NT101600CUNITI Orthodontic Wire-NT101800NITI Orthodontic Wire-NT101800CUPre-cut Ligature Ties-010RCS-Lower-16RCS-Lower-16*16RCS-Lower-16*22RCS-Lower-17*25RCS-Lower-18RCS-Lower-18*25RCS-Lower-19*25RCS-Upper-16RCS-Upper-16*16RCS-Upper-16*22RCS-Upper-17*25RCS-Upper-18RCS-Upper-18*25RCS-Upper-19*25Seven Strand (twisted) 0155Seven Strand (twisted) 0175SS Archwire-Lower-12SS Archwire-Lower-14SS Archwire-Lower-16SS Archwire-Lower-16*16SS Archwire-Lower-16*22SS Archwire-Lower-17*25SS Archwire-Lower-18SS Archwire-Lower-18*25SS Archwire-Lower-19*25SS Archwire-Lower-21*25SS Archwire-Upper-12SS Archwire-Upper-14SS Archwire-Upper-16SS Archwire-Upper-16*16SS Archwire-Upper-16*22SS Archwire-Upper-17*25SS Archwire-Upper-18SS Archwire-Upper-18*25SS Archwire-Upper-19*25SS Archwire-Upper-21*25Stainless Steel Ligature Ties-010Stainless Steel Ligature Ties-012Stainless Steel Orthodontic Wire-SS011616Stainless Steel Orthodontic Wire-SS011622Stainless Steel Orthodontic Wire-SS011722Stainless Steel Orthodontic Wire-SS011725Stainless Steel Orthodontic Wire-SS011822Stainless Steel Orthodontic Wire-SS011825Stainless Steel Orthodontic Wire-SS011922Stainless Steel Orthodontic Wire-SS011925Stainless Steel Orthodontic Wire-SS111616Stainless Steel Orthodontic Wire-SS111622Stainless Steel Orthodontic Wire-SS111722Stainless Steel Orthodontic Wire-SS111725Stainless Steel Orthodontic Wire-SS111822Stainless Steel Orthodontic Wire-SS111825Stainless Steel Orthodontic Wire-SS111922Stainless Steel Orthodontic Wire-SS111925Thermal-Niti-Lower-12Thermal-Niti-Lower-14Thermal-Niti-Lower-16Thermal-Niti-Lower-16*16Thermal-Niti-Lower-16*22Thermal-Niti-Lower-17x25Thermal-Niti-Lower-18Thermal-Niti-Lower-18x18Thermal-Niti-Lower-18x25Thermal-Niti-Lower-19x25Thermal-Niti-Upper-12Thermal-Niti-Upper-14Thermal-Niti-Upper-16Thermal-Niti-Upper-16*16Thermal-Niti-Upper-16*22Thermal-Niti-Upper-17*25Thermal-Niti-Upper-18Thermal-Niti-Upper-18*18Thermal-Niti-Upper-18*25Thermal-Niti-Upper-19*25TMA-Lower-16*22TMA-Lower-17*25TMA-Lower-18*25TMA-Upper-16*22TMA-Upper-17*25TMA-Upper-18*25Universal From-SS-12Universal From-SS-14Universal From-SS-14*25Universal From-SS-16Universal From-SS-16*16Universal From-SS-16*25Universal From-SS-17*25Universal From-SS-18Universal From-SS-18*25Universal From-SS-19*25Universal-TMA14*25Universal-TMA16*25Universal-TMA17*25Universal-TMA18*25Universal-TMA19*25Universal-TMA21*25 | 2019 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Maker | SD Mini Tube LL7-DQ18SD Mini Tube LL7-DQ22SD Mini Tube LL7-EDGEWISE18SD Mini Tube LL7-EDGEWISE22SD Mini Tube LR7-DQ18SD Mini Tube LR7-DQ22SD Mini Tube LR7-EDGEWISE18SD Mini Tube LR7-EDGEWISE22SD Mini Tube UL7-DQ18SD Mini Tube UL7-DQ22 78 moreSD Mini Tube UL7-EDGEWISE18SD Mini Tube UL7-EDGEWISE22SD Mini Tube UR7-DQ18SD Mini Tube UR7-DQ22SD Mini Tube UR7-EDGEWISE18SD Mini Tube UR7-EDGEWISE22SD Tube DBL Conv.LL6-MBT18SD Tube DBL Conv.LL6-MBT22SD Tube DBL Conv.LL6-ROTH18SD Tube DBL Conv.LL6-ROTH22SD Tube DBL Conv.LR6-MBT18SD Tube DBL Conv.LR6-MBT22SD Tube DBL Conv.LR6-ROTH18SD Tube DBL Conv.LR6-ROTH22SD Tube DBL Conv.UL6-MBT18SD Tube DBL Conv.UL6-MBT22SD Tube DBL Conv.UL6-ROTH18SD Tube DBL Conv.UL6-ROTH22SD Tube DBL Conv.UR6-MBT18SD Tube DBL Conv.UR6-MBT22SD Tube DBL Conv.UR6-ROTH18SD Tube DBL Conv.UR6-ROTH22SD Tube SGL Conv.LL6-MBT18SD Tube SGL Conv.LL6-MBT22SD Tube SGL Conv.LL6-ROTH18SD Tube SGL Conv.LL6-ROTH22SD Tube SGL Conv.LR6-MBT18SD Tube SGL Conv.LR6-MBT22SD Tube SGL Conv.LR6-ROTH18SD Tube SGL Conv.LR6-ROTH22SD Tube SGL Conv.UL6-MBT18SD Tube SGL Conv.UL6-MBT22SD Tube SGL Conv.UL6-ROTH18SD Tube SGL Conv.UL6-ROTH22SD Tube SGL Conv.UR6-MBT18SD Tube SGL Conv.UR6-MBT22SD Tube SGL Conv.UR6-ROTH18SD Tube SGL Conv.UR6-ROTH22SD Tube SGL LL6-DQ22SD Tube SGL LL6-MBT18SD Tube SGL LL6-MBT22SD Tube SGL LL6-ROTH18SD Tube SGL LL6-ROTH22SD Tube SGL LL7-DQ22SD Tube SGL LL7-MBT18SD Tube SGL LL7-MBT22SD Tube SGL LL7-ROTH18SD Tube SGL LL7-ROTH22SD Tube SGL LR6-DQ22SD Tube SGL LR6-MBT18SD Tube SGL LR6-MBT22SD Tube SGL LR6-ROTH18SD Tube SGL LR6-ROTH22SD Tube SGL LR7-DQ22SD Tube SGL LR7-MBT18SD Tube SGL LR7-MBT22SD Tube SGL LR7-ROTH18SD Tube SGL LR7-ROTH22SD Tube SGL UL6-DQ22SD Tube SGL UL6-MBT18SD Tube SGL UL6-MBT22SD Tube SGL UL6-ROTH18SD Tube SGL UL6-ROTH22SD Tube SGL UL7-DQ22SD Tube SGL UL7-MBT18SD Tube SGL UL7-MBT22SD Tube SGL UL7-ROTH18SD Tube SGL UL7-ROTH22SD Tube SGL UR6-DQ22SD Tube SGL UR6-MBT18SD Tube SGL UR6-MBT22SD Tube SGL UR6-ROTH18SD Tube SGL UR6-ROTH22SD Tube SGL UR7-DQ22SD Tube SGL UR7-MBT18SD Tube SGL UR7-MBT22SD Tube SGL UR7-ROTH18SD Tube SGL UR7-ROTH22 | 2019 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | AL HANDLE LAL HANDLE SAS ALGLE BLADE LAS ANGLE BLADE SAS BLADE LAS BLADE SFT ANGLE BLADE LFT ANGLE BLADE SFT BLADE LFT BLADE S 12 moreIS ANGLE BLADE LIS ANGLE BLADE SIS BLADE LIS BLADE SMS ANGLE BLADE LMS ANGLE BLADE SMS BLADE LMS BLADE SPS ANGLE BLADE LPS ANGLE BLADE SPS BLADE LPS BLADE S | 2025 |
| Orthodontic Wire ClampECN · Class 1 | — | Maker | Arm Hook-X typeBall Hook-X typeC-Hook(L)-X typeC-Hook(R)-X typeStopper-Tubular Ti IIStopper-Tubular Ti VISTOPS-X typeT-Hook(M)-X typeT-Hook(S)-X type | 2019 |
| Orthodontic SpringECO · Class 1 | Orthodontic wires & bands | Maker | ART-Large-LowerART-Large-UpperART-Middle-LowerART-Middle-UpperART-Small-LowerART-Small-UpperNiTi Close Spring-10*180mmNiTi Close Spring-12*180mmNiTi closed spring(1.5)13mm150NiTi closed spring(1.5)13mm200 19 moreNiTi closed spring(1.5)13mm250NiTi closed spring(1.5)8mm150gNiTi closed spring(1.5)8mm200gNiTi closed spring(1.5)8mm250gNiTi closed spring(2.5)13mm150NiTi closed spring(2.5)13mm200NiTi closed spring(2.5)13mm250NiTi closed spring(2.5)8mm150gNiTi closed spring(2.5)8mm200gNiTi closed spring(2.5)8mm250gNiTi Open Spring-10*180mmNiTi Open Spring-12*180mmTorquing Spring-16*22 LTorquing Spring-16*22 MTorquing Spring-17*25 LTorquing Spring-17*25 MTorquing Spring-18*25 LTorquing Spring-18*25 MTorquing Spring-19*25M | 2025 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | Classic Mini B.MBT18 (345H)Classic Mini B.MBT18 LL1(W/O)Classic Mini B.MBT18 LL2(W/O)Classic Mini B.MBT18 LL3(W/H)Classic Mini B.MBT18 LL4(W/H)Classic Mini B.MBT18 LL5(W/H)Classic Mini B.MBT18 LR1(W/O)Classic Mini B.MBT18 LR2(W/O)Classic Mini B.MBT18 LR3(W/H)Classic Mini B.MBT18 LR4(W/H) 356 moreClassic Mini B.MBT18 LR5(W/H)Classic Mini B.MBT18 UL1(W/O)Classic Mini B.MBT18 UL2(W/O)Classic Mini B.MBT18 UL3(W/H)Classic Mini B.MBT18 UL4(W/H)Classic Mini B.MBT18 UL5(W/H)Classic Mini B.MBT18 UR1(W/O)Classic Mini B.MBT18 UR2(W/O)Classic Mini B.MBT18 UR3(W/H)Classic Mini B.MBT18 UR4(W/H)Classic Mini B.MBT18 UR5(W/H)Classic Mini B.MBT22 (345H)Classic Mini B.MBT22 LL1(W/O)Classic Mini B.MBT22 LL2(W/O)Classic Mini B.MBT22 LL3(W/H)Classic Mini B.MBT22 LL4(W/H)Classic Mini B.MBT22 LL5(W/H)Classic Mini B.MBT22 LR1(W/O)Classic Mini B.MBT22 LR2(W/O)Classic Mini B.MBT22 LR3(W/H)Classic Mini B.MBT22 LR4(W/H)Classic Mini B.MBT22 LR5(W/H)Classic Mini B.MBT22 UL1(W/O)Classic Mini B.MBT22 UL2(W/O)Classic Mini B.MBT22 UL3(W/H)Classic Mini B.MBT22 UL4(W/H)Classic Mini B.MBT22 UL5(W/H)Classic Mini B.MBT22 UR1(W/O)Classic Mini B.MBT22 UR2(W/O)Classic Mini B.MBT22 UR3(W/H)Classic Mini B.MBT22 UR4(W/H)Classic Mini B.MBT22 UR5(W/H)Classic Mini B.ROTH18 (345H)Classic Mini B.ROTH18 LL1(W/O)Classic Mini B.ROTH18 LL2(W/O)Classic Mini B.ROTH18 LR1(W/O)Classic Mini B.ROTH18 LR2(W/O)Classic Mini B.ROTH18 UL1(W/O)Classic Mini B.ROTH18 UL2(W/O)Classic Mini B.ROTH18 UR1(W/O)Classic Mini B.ROTH18 UR2(W/O)Classic Mini B.ROTH18LL3(W/H)Classic Mini B.ROTH18LL4(W/H)Classic Mini B.ROTH18LL5(W/H)Classic Mini B.ROTH18LR3(W/H)Classic Mini B.ROTH18LR4(W/H)Classic Mini B.ROTH18LR5(W/H)Classic Mini B.ROTH18UL3(W/H)Classic Mini B.ROTH18UL4(W/H)Classic Mini B.ROTH18UL5(W/H)Classic Mini B.ROTH18UR3(W/H)Classic Mini B.ROTH18UR4(W/H)Classic Mini B.ROTH18UR5(W/H)Classic Mini B.ROTH22 (345H)Classic Mini B.ROTH22 LL1(W/O)Classic Mini B.ROTH22 LL2(W/O)Classic Mini B.ROTH22 LR1(W/O)Classic Mini B.ROTH22 LR2(W/O)Classic Mini B.ROTH22 UL1(W/O)Classic Mini B.ROTH22 UL2(W/O)Classic Mini B.ROTH22 UR1(W/O)Classic Mini B.ROTH22 UR2(W/O)Classic Mini B.ROTH22LL3(W/H)Classic Mini B.ROTH22LL4(W/H)Classic Mini B.ROTH22LL5(W/H)Classic Mini B.ROTH22LR3(W/H)Classic Mini B.ROTH22LR4(W/H)Classic Mini B.ROTH22LR5(W/H)Classic Mini B.ROTH22UL3(W/H)Classic Mini B.ROTH22UL4(W/H)Classic Mini B.ROTH22UL5(W/H)Classic Mini B.ROTH22UR3(W/H)Classic Mini B.ROTH22UR4(W/H)Classic Mini B.ROTH22UR5(W/H)Function SLB HookFunction SLB InstrumentFunction SLB-High22Function SLB-High22 LL1Function SLB-High22 LL2Function SLB-High22 LL3Function SLB-High22 LL4Function SLB-High22 LL5Function SLB-High22 LR1Function SLB-High22 LR2Function SLB-High22 LR3Function SLB-High22 LR4Function SLB-High22 LR5Function SLB-High22 UL1Function SLB-High22 UL2Function SLB-High22 UL3Function SLB-High22 UL4Function SLB-High22 UL5Function SLB-High22 UR1Function SLB-High22 UR2Function SLB-High22 UR3Function SLB-High22 UR4Function SLB-High22 UR5Function SLB-Low22Function SLB-Low22 LL1Function SLB-Low22 LL2Function SLB-Low22 LL3Function SLB-Low22 LL4Function SLB-Low22 LL5Function SLB-Low22 LR1Function SLB-Low22 LR2Function SLB-Low22 LR3Function SLB-Low22 LR4Function SLB-Low22 LR5Function SLB-Low22 UL1Function SLB-Low22 UL2Function SLB-Low22 UL3Function SLB-Low22 UL4Function SLB-Low22 UL5Function SLB-Low22 UR1Function SLB-Low22 UR2Function SLB-Low22 UR3Function SLB-Low22 UR4Function SLB-Low22 UR5Function SLB-MBT18Function SLB-MBT18 LL1Function SLB-MBT18 LL2Function SLB-MBT18 LL3Function SLB-MBT18 LL4Function SLB-MBT18 LL5Function SLB-MBT18 LR1Function SLB-MBT18 LR2Function SLB-MBT18 LR3Function SLB-MBT18 LR4Function SLB-MBT18 LR5Function SLB-MBT18 UL1Function SLB-MBT18 UL2Function SLB-MBT18 UL3Function SLB-MBT18 UL4Function SLB-MBT18 UL5Function SLB-MBT18 UR1Function SLB-MBT18 UR2Function SLB-MBT18 UR3Function SLB-MBT18 UR4Function SLB-MBT18 UR5Function SLB-MBT22 | 2019 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | Root Canal Files M1-C Single #10 19mmRoot Canal Files M1-C Single #10 21mmRoot Canal Files M1-C Single #10 25mmRoot Canal Files M1-C Single #10 31mmRoot Canal Files M1-C Single #12 19mmRoot Canal Files M1-C Single #12 21mmRoot Canal Files M1-C Single #12 25mmRoot Canal Files M1-C Single #12 31mmRoot Canal Files M1-C Single #15 19mmRoot Canal Files M1-C Single #15 21mm 277 moreRoot Canal Files M1-C Single #15 25mmRoot Canal Files M1-C Single #15 31mmRoot Canal Files M1-C Single #6 19mmRoot Canal Files M1-C Single #6 21mmRoot Canal Files M1-C Single #6 25mmRoot Canal Files M1-C Single #6 31mmRoot Canal Files M1-C Single #8 19mmRoot Canal Files M1-C Single #8 21mmRoot Canal Files M1-C Single #8 25mmRoot Canal Files M1-C Single #8 31mmRoot Canal Files M1-H Assorted L 21mmRoot Canal Files M1-H Assorted L 25mmRoot Canal Files M1-H Assorted L 31mmRoot Canal Files M1-H Assorted S 21mmRoot Canal Files M1-H Assorted S 25mmRoot Canal Files M1-H Assorted S 31mmRoot Canal Files M1-H Single #10 21mmRoot Canal Files M1-H Single #10 25mmRoot Canal Files M1-H Single #10 31mmRoot Canal Files M1-H Single #15 21mmRoot Canal Files M1-H Single #15 25mmRoot Canal Files M1-H Single #15 31mmRoot Canal Files M1-H Single #20 21mmRoot Canal Files M1-H Single #20 25mmRoot Canal Files M1-H Single #20 31mmRoot Canal Files M1-H Single #25 21mmRoot Canal Files M1-H Single #25 25mmRoot Canal Files M1-H Single #25 31mmRoot Canal Files M1-H Single #30 21mmRoot Canal Files M1-H Single #30 25mmRoot Canal Files M1-H Single #30 31mmRoot Canal Files M1-H Single #35 21mmRoot Canal Files M1-H Single #35 25mmRoot Canal Files M1-H Single #35 31mmRoot Canal Files M1-H Single #40 21mmRoot Canal Files M1-H Single #40 25mmRoot Canal Files M1-H Single #40 31mmRoot Canal Files M1-H Single #45 21mmRoot Canal Files M1-H Single #45 25mmRoot Canal Files M1-H Single #45 31mmRoot Canal Files M1-H Single #50 21mmRoot Canal Files M1-H Single #50 25mmRoot Canal Files M1-H Single #50 31mmRoot Canal Files M1-H Single #55 21mmRoot Canal Files M1-H Single #55 25mmRoot Canal Files M1-H Single #55 31mmRoot Canal Files M1-H Single #6 21mmRoot Canal Files M1-H Single #6 25mmRoot Canal Files M1-H Single #6 31mmRoot Canal Files M1-H Single #60 21mmRoot Canal Files M1-H Single #60 25mmRoot Canal Files M1-H Single #60 31mmRoot Canal Files M1-H Single #8 21mmRoot Canal Files M1-H Single #8 25mmRoot Canal Files M1-H Single #8 31mmRoot Canal Files M1-K Assorted L 21mmRoot Canal Files M1-K Assorted L 25mmRoot Canal Files M1-K Assorted L 31mmRoot Canal Files M1-K Assorted S 21mmRoot Canal Files M1-K Assorted S 25mmRoot Canal Files M1-K Assorted S 31mmRoot Canal Files M1-K Single #10 21mmRoot Canal Files M1-K Single #10 25mmRoot Canal Files M1-K Single #10 31mmRoot Canal Files M1-K Single #15 21mmRoot Canal Files M1-K Single #15 25mmRoot Canal Files M1-K Single #15 31mmRoot Canal Files M1-K Single #20 21mmRoot Canal Files M1-K Single #20 25mmRoot Canal Files M1-K Single #20 31mmRoot Canal Files M1-K Single #25 21mmRoot Canal Files M1-K Single #25 25mmRoot Canal Files M1-K Single #25 31mmRoot Canal Files M1-K Single #30 21mmRoot Canal Files M1-K Single #30 25mmRoot Canal Files M1-K Single #30 31mmRoot Canal Files M1-K Single #35 21mmRoot Canal Files M1-K Single #35 25mmRoot Canal Files M1-K Single #35 31mmRoot Canal Files M1-K Single #40 21mmRoot Canal Files M1-K Single #40 25mmRoot Canal Files M1-K Single #40 31mmRoot Canal Files M1-K Single #45 21mmRoot Canal Files M1-K Single #45 25mmRoot Canal Files M1-K Single #45 31mmRoot Canal Files M1-K Single #50 21mmRoot Canal Files M1-K Single #50 25mmRoot Canal Files M1-K Single #50 31mmRoot Canal Files M1-K Single #55 21mmRoot Canal Files M1-K Single #55 25mmRoot Canal Files M1-K Single #55 31mmRoot Canal Files M1-K Single #6 21mmRoot Canal Files M1-K Single #6 25mmRoot Canal Files M1-K Single #6 31mmRoot Canal Files M1-K Single #60 21mmRoot Canal Files M1-K Single #60 25mmRoot Canal Files M1-K Single #60 31mmRoot Canal Files M1-K Single #8 21mmRoot Canal Files M1-K Single #8 25mmRoot Canal Files M1-K Single #8 31mmRoot Canal Files M1-L Single L1(20/07) 25mmRoot Canal Files M1-L Single L2(25/065) 25mmRoot Canal Files M1-L Single L3(35/06) 25mmRoot Canal Files M1-L Single L4(45/05) 25mmRoot Canal Files M1-L Single L5(55/04) 25mmRoot Canal Files M1-L Single L6(25/04) 25mmRoot Canal Files M1-L Single L7(30/04) 25mmRoot Canal Files M1-M Assorted 21mmRoot Canal Files M1-M Assorted 25mmRoot Canal Files M1-M Assorted 31mmRoot Canal Files M1-M Single (17/08) 19mmRoot Canal Files M1-M Single (19/02) 21mmRoot Canal Files M1-M Single (19/02) 25mmRoot Canal Files M1-M Single (19/02) 31mmRoot Canal Files M1-M Single (20/04) 21mmRoot Canal Files M1-M Single (20/04) 25mmRoot Canal Files M1-M Single (20/04) 31mmRoot Canal Files M1-M Single (25/04) 21mmRoot Canal Files M1-M Single (25/04) 25mmRoot Canal Files M1-M Single (25/04) 31mmRoot Canal Files M1-M Single (25/06) 21mmRoot Canal Files M1-M Single (25/06) 25mmRoot Canal Files M1-M Single (25/06) 31mmRoot Canal Files M1-M Single (30/04) 21mmRoot Canal Files M1-M Single (30/04) 25mmRoot Canal Files M1-M Single (30/04) 31mmRoot Canal Files M1-M Single (30/06) 21mmRoot Canal Files M1-M Single (30/06) 25mmRoot Canal Files M1-M Single (30/06) 31mmRoot Canal Files M1-M Single (35/04) 21mmRoot Canal Files M1-M Single (35/04) 25mmRoot Canal Files M1-M Single (35/04) 31mmRoot Canal Files M1-MaxI Single (25/02) 21mmRoot Canal Files M1-MaxI Single (25/02) 25mmRoot Canal Files M1-MaxII Single (25/02) 21mmRoot Canal Files M1-MaxII Single (25/02) 25mmRoot Canal Files M1-P Assorted 21mmRoot Canal Files M1-P Assorted 25mmRoot Canal Files M1-P Assorted 31mmRoot Canal Files M1-P Single F1(20/07) 21mm | 2025 |
| Orthodontic Endosseous ImplantOAT · Class 2 | — | Maker | AS Orthodontic Screw 1.5mm L07mm round hole SSAS Orthodontic Screw 1.5mm L07mm round hole TiAS Orthodontic Screw 1.5mm L07mm square hole SSAS Orthodontic Screw 1.5mm L07mm square hole TiAS Orthodontic Screw 2mm L07mm round hole SSAS Orthodontic Screw 2mm L07mm round hole TiAS Orthodontic Screw 2mm L07mm square hole SSAS Orthodontic Screw 2mm L07mm square hole TiCS Orthodontic Screw 1.5mm L07mm round hole SSCS Orthodontic Screw 1.5mm L07mm round hole Ti 44 moreCS Orthodontic Screw 1.5mm L07mm square hole SSCS Orthodontic Screw 1.5mm L07mm square hole TiCS Orthodontic Screw 2mm L07mm round hole SSCS Orthodontic Screw 2mm L07mm round hole TiCS Orthodontic Screw 2mm L07mm square hole SSCS Orthodontic Screw 2mm L07mm square hole TiHS Orthodontic Screw 1.5mm L07mm No hole SSHS Orthodontic Screw 1.5mm L07mm No hole TiHS Orthodontic Screw 1.5mm L07mm round hole SSHS Orthodontic Screw 1.5mm L07mm round hole TiHS Orthodontic Screw 1.5mm L07mm square hole SSHS Orthodontic Screw 1.5mm L07mm square hole TiHS Orthodontic Screw 2mm L07mm No hole SSHS Orthodontic Screw 2mm L07mm No hole TiHS Orthodontic Screw 2mm L07mm round hole SSHS Orthodontic Screw 2mm L07mm round hole TiHS Orthodontic Screw 2mm L07mm square hole SSHS Orthodontic Screw 2mm L07mm square hole TiMS Orthodontic Screw 1.5mm L07mm round hole SSMS Orthodontic Screw 1.5mm L07mm round hole TiNS Orthodontic Screw 1.5mm L07mm Ditchless SSNS Orthodontic Screw 1.5mm L07mm Ditchless TiNS Orthodontic Screw 1.5mm L07mm Two grooves SSNS Orthodontic Screw 1.5mm L07mm Two grooves TiNS Orthodontic Screw 2mm L07mm Ditchless SSNS Orthodontic Screw 2mm L07mm Ditchless TiNS Orthodontic Screw 2mm L07mm Two grooves SSNS Orthodontic Screw 2mm L07mm Two grooves TiPS Orthodontic Screw 1.5mm L07mm round hole SSPS Orthodontic Screw 1.5mm L07mm round hole TiPS Orthodontic Screw 1.5mm L07mm square hole SSPS Orthodontic Screw 1.5mm L07mm square hole TiPS Orthodontic Screw 2mm L07mm round hole SSPS Orthodontic Screw 2mm L07mm round hole TiPS Orthodontic Screw 2mm L07mm square hole SSPS Orthodontic Screw 2mm L07mm square hole TiWS Orthodontic Screw 1.5mm L07mm round hole SSWS Orthodontic Screw 1.5mm L07mm round hole TiWS Orthodontic Screw 1.5mm L07mm square hole SSWS Orthodontic Screw 1.5mm L07mm square hole TiWS Orthodontic Screw 2mm L07mm round hole SSWS Orthodontic Screw 2mm L07mm round hole TiWS Orthodontic Screw 2mm L07mm square hole SSWS Orthodontic Screw 2mm L07mm square hole Ti | 2025 |
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 |
|---|---|---|
| ZE FANG TECHNOLOGY CO., LTD.FDA reg. 3013689189 | Taichung, Taiwan | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10062228). 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.