Manufacturer registered with FDA
Mozograu S.A.
Valladolid, Spain. 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
- 300
- 510(k) clearances
- 12024–2024
- Markets registered in
- 634 registrations outside the US
- Establishments
- 1Spain
510(k) clearances per year, 2007–2026
Registered in 6 markets
Where regulators' registries name Mozograu S.A. as the manufacturer or the registration holder of a device.
RegisteredHome: SpainOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Mozograu S.A. | 1 clearances | 2024–2024 | Below |
| European Union | EUDAMED | Manufacturer | MOZO GRAU SA | 25 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | MOZO GRAU S.A. | 3 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | MOZO GRAU, S.L. | 3 | 2010–2010 | Pure Global AI |
| China | NMPA | Registration holder | 西班牙泰科公司 MOZO GRAU, S.A.西班牙泰科公司MOZO-GRAU,S.A. | 2 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | MOZO-GRAU, S.A. | 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 Mozograu S.A. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | Ticare Dental Implant Systems | 2024 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Analog 10º tap abut Os Std-Maxi PS/In Std-MaxAnalog 30º tap abut Os Std-Maxi PS/In Std-MaxAnalogue for 10º Tap.abut. Maxi OssAnalogue for 10º Tap.abut. Mini Oss/InhAnalogue for 30º Tap.abut. Maxi OssAnalogue for Implant Maxi InhexAnalogue for Implant Mini InhexAnalogue for Implant Std InhexAnalogue for Multiunit abutBasic Stoppers tray 271 moreBone grafting and membranes trayBroken prosthesis extraction wrench InHex MaxiBroken prosthesis extraction wrench InHex Mini/StdBroken screws ext. In Mn reamerBroken screws ext. Os Mn-Os St-In St reamerBroken screws ext. Os Mx-In Mx reamerC/a Fidelis 4 punchCounterwise tool for In StCounterwise tool for Os Mn-Os St-In MxCounterwise tool for Os Mx-In MnDigital Analogue multiunit abutment with screwDrill 3,3-3,4 stop L10 mmDrill 3,3-3,4 stop L11,5 mmDrill 3,3-3,4 stop L13 mmDrill 3,3-3,4 stop L15 mmDrill 3,3-3,4 stop L6 mmDrill 3,3-3,4 stop L8 mmDrill 3,3-3,4 stop L9 mmDrill 3,75-4,25 stop L10 mmDrill 3,75-4,25 stop L11,5 mmDrill 3,75-4,25 stop L13 mmDrill 3,75-4,25 stop L15 mmDrill 3,75-4,25 stop L6 mmDrill 3,75-4,25 stop L8 mmDrill 3,75-4,25 stop L9 mmDrill 5 stop L10 mmDrill 5 stop L11,5 mmDrill 5 stop L13 mmDrill 5 stop L15 mmDrill 5 stop L6 mmDrill 5 stop L8 mmDrill 5 stop L9 mmDrill extenderDynamometric removable ratchet wrench 250 NcmExpanders trayExplantation screw for Maxi Inhex implantExplantation screw for Maxi Osseous implantExplantation screw for Mini Inhex implantExplantation screw for Mini-Std Osseous implantExplantation screw for Std Inhex implantExplantation tool for 3,75 Std Inhex implantExplantation tool for 4,25 Std Inhex implantExplantation tool for Maxi Inhex implantExplantation tool for Maxi Osseous implantExplantation tool for Mini Inhex implantExplantation tool for Mini Osseous implantExplantation tool for Std Osseous implantExplantation trayExtenders Fidelis handleExtraoral screwdriver handleFidelis 6mm long drillFidelis Plus trayFidelis trayFlat C/a screwdriver l. 14 mmFlat screwdriver ratchet for 7mm l. 14 mmHex Aesthetic Imp coping Std Inhex +screwHex Aesthetic Imp.cop. Std. Oss. +screwHex Aesthetic impr. coping Maxi Inhex +screwHex Aesthetic impr. coping Maxi Oss. +screwHex Aesthetic impr. coping Std. Oss. +screwHex impr. coping Maxi Inhex +screwHex impr. coping Maxi Inhex +screw TCPHex impr. coping Maxi Oss. +screwHex impr. coping Mini Inhex +screwHex impr. coping Mini Oss. +screwHex impr. coping Std. Oss. +screwHex Impresion coping Inhex Mini + screw TCPHex Impresion coping Inhex Std + screwHex Impresion coping Inhex Std + screw TCPHex long impr. coping Maxi Inhex +screwHex long impr. coping Mini Oss. +screwHex long impr. coping Std. Inhex +screwHex. dynamometric ratchet adapterHex. for c/a adapterImplant Analogue for Maxi OsseousImplant Analogue for Mini OsseousImplant Analogue for Std OsseousImplant insertion toolImpr. coping for 10º Tap.abut. Oss/Inh +screwImpression coping for MultiunitInhex + Quattro Compact TrayInhex Fidelis mount driveInhex-Osseous Explantation SheetLong Hex C/a Torque ScrewdriverLong Hex Ratchet Torque ScrewdriverLong Hex. C/a 1.25 screwdriver l. 14 mmLong Hex. for c/a adapterLong hex. imp. coping abut Maxi Inhex + screw TCPLong hex. imp. coping abut Mini Inhex + screw TCPLong hex. imp. coping abut Std Inhex + screw TCPLong hex. imp. coping abutment Maxi Inhex + screwLong hex. imp. coping abutment Mini Inhex + screwLong hex. imp. coping abutment Std Inhex + screwLong Maxi Inhex removerLong Maxi Osseous removerLong Mini Inhex removerLong Mini Osseous removerLong Std Inhex removerLong Std Osseous removerMaxi depth gauge 6 mm depth markMAXI Inhex Digital Analogue with screwMaxi Inhex Long implant mount 20 mm w/sMaxi Inhex removerMAXI Osseous Digital Analogue with screwMaxi Osseous Long implant mount 20 mm w/sMaxi Osseous removerMaxi paralelling PinMembranes trayMini depth gauge 6 mm depth markMINI Inhex Digital Analogue with screwMini Inhex Long implant mount 20 mm w/sMini Inhex removerMINI Osseous Digital Analogue with screwMini Osseous Long implant mount 20 mm w/sMini Osseous removerMini paralelling PinModular Surgical Container BoxModular Surgical Container Box MediumMount drive exchange holderMulticonverterNon hex Aesthetic impr. coping Maxi InhexNon hex Aesthetic impr. coping Std. InhexNon hex Aesthetic impr. coping Std. Oss.Non hex impr. coping Maxi InhexNon hex impr. coping Maxi Oss.Non hex impr. coping Mini Oss.Non hex impr. coping Std. InhexNon hex impr. coping Std. Oss. w/sNon hex long impr. coping Maxi InhexNon hex long impr. coping Std. InhexOs St-Mx PS/In St-Mx Digital Analogue 10º tapered abutment with screwOs St-Mx PS/In St-Mx Digital Analogue 30º tapered abutment with screwOsseous Fidelis mount driveOsseous Maxi Digital Analogue 10º tapered abutment with screwOsseous Maxi Digital Analogue 30º tapered abutment with screwOsseous Std Digital Analogue with screwOsseous-Inhex + Quattro Compact TrayOsseous-Inhex 1/2 Quattro trayOsseous-Inhex Mini Digital Analogue 10º tapered abutment with screwPin fix Fidelis | 2024 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | Ticare Dental Implant Systems | 2024 |
| Non-Irrigation Endosseous Dental Implant Drill BitsQRQ · Class 1 | Implant instruments & surgical kits | Maker | Fidelis Crestal DrillTC Fidelis 3,2x10 drillTC Fidelis 3,2x11 drillTC Fidelis 3,2x13 drillTC Fidelis 3,2x8 drillTC Fidelis 3,3 Quattro profile drillTC Fidelis 3,5x10 drillTC Fidelis 3,5x11 drillTC Fidelis 3,5x13 drillTC Fidelis 3,5x8 drill 7 moreTC Fidelis 3,75 Quattro profile drillTC Fidelis 4,0x10 drillTC Fidelis 4,0x11 drillTC Fidelis 4,0x13 drillTC Fidelis 4,0x8 drillTC Fidelis 4,25 Quattro profile drill0.7 Dia. L9 mm Drill | 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 |
|---|---|---|
| MOZO-GRAU SAFDA reg. 3031553803 | Valladolid, Spain | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10090922). 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.