FDA Registration
Active
🇪🇸 Spain
MOZO-GRAU SA
Reg #: 3031553803
·
FEI: 3031553803
·
Expires 2026
Products
4
Proprietary Names
299
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- MOZO-GRAU SA
- Registration Number
- 3031553803
- FEI Number
- 3031553803
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Santiago Lopez Gonzalez 7
- City
- Valladolid
- Country
- ES
Regulatory Submissions
- 510(k) Number
- K233137
Owner / Operator
- Firm Name
- MOZO-GRAU SA
- Operator Number
- 10090922
- Address
- Santiago Lopez Gonzalez 7
- City
- Valladolid
- State
- ES-VA
- Postal Code
- 47197
- Country
- ES
- Correspondent
- Beatriz Santos
US Agent
- Business Name
- PHARMA-BIO SERV, INC.
- Contact Name
- Victor Sanchez Altura
- Address
- 6 Road 696
- City
- Dorado
- State
- PR
- ZIP
- 00646
- Country
- US
- [email protected]
- Phone
- 787 5072911
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2024-06-03 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2024-06-03 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2024-07-08 |
| Non-Irrigation Endosseous Dental Implant Drill Bits | QRQ | Class 1 | Dental | No | 2026-03-27 |
Proprietary Names
Ticare Dental Implant Systems
1,3 Dia. square C/a screwdriver L10 mm
Bone grafting and membranes tray
Extenders Fidelis handle
0,9 Hex. C/a screwdriver L9 mm
Counterwise tool for In St
Broken prosthesis extraction wrench InHex Mini/Std
4,25 Osseous/Inhex bone tap l. 16mm 6mm mark
Counterwise tool for Os Mn-Os St-In Mx
Drill 3,3-3,4 stop L6 mm
Short hex. imp. coping abutment Std Inhex + screw
Rot. Imp.cop. for 10º Tap.abut. Max Oss/Inh
Explantation tool for 4,25 Std Inhex implant
Drill 5 stop L13 mm
TC Fidelis 3,3x11,5 drill
4,3 RCD long helix drill l. 21 mm 6mm mark
Mini Inhex remover
Fidelis 6mm long drill
Drill 3,75-4,25 stop L10 mm
4,9 helix hard bones drill l. 16 mm RCD 6mm mark
4,25 RCD Quattro profile drill
Hex impr. coping Maxi Oss. +screw
Drill 5 stop L6 mm
Multiconverter
TC Fidelis 3,3x8 drill
Ratchet wrench 7mm dia
Non hex Aesthetic impr. coping Maxi Inhex
Rot. Imp.cop. for 10º Tap.abut. Oss/Inh Maxi+screw
Analogue for Implant Maxi Inhex
RCD Quattro guiding drill diameter 3
Maxi Osseous remover
2 initial drill l. 13 mm 6 mm mark
4.1 Fidelis Oss countersink l.11.50 mm
2,8 mm angled expander osteotome
Mini depth gauge 6 mm depth mark
2 mm angled expander osteotome
1.25 Hex. screwdr. for 7mm. dia. ratchet l. 14 mm
Hex Aesthetic impr. coping Maxi Inhex +screw
Drill 3,3-3,4 stop L9 mm
Hex impr. coping Mini Inhex +screw
Short Hex C/a Torque Screwdriver
Explantation screw for Maxi Inhex implant
Hex long impr. coping Std. Inhex +screw
Inhex Fidelis mount drive
Osseous-Inhex + Quattro Compact Tray
3,8 RCD helix drill l. 16 mm 6mm mark
Subcrestal profile drill 4,1-4,5 mm Platform
Short Hex. C/a 1.25 screwdriver l. 9 mm
Explantation tool for Mini Inhex implant
Drill 3,75-4,25 stop L8 mm
Mini paralelling Pin
2 mm concave sinus lift osteotome
Analog 30º tap abut Os Std-Maxi PS/In Std-Max
Non hex impr. coping Std. Inhex
Flat screwdriver ratchet for 7mm l. 14 mm
3,75 Osseous/Inhex bone tap l. 16mm 6mm mark
Osseous-Inhex 1/2 Quattro tray
TC Fidelis 3x11,5 drill
4,3 RCD helix drill l. 16 mm 6mm mark
Non hex impr. coping Std. Oss. w/s
Implant insertion tool
20 long helix drill 6 mm depth mark l. 21 mm
TC Fidelis 2x10 drill
Broken screws ext. In Mn reamer
3,5 helix hard bones drill l. 16 mm RCD 6mm mark
Drill 3,3-3,4 stop L11,5 mm
TC Fidelis 2x11,5 drill
Long Hex Ratchet Torque Screwdriver
Non hex Aesthetic impr. coping Std. Oss.
Non hex long impr. coping Maxi Inhex
Std paralelling Pin
Explantation tool for Mini Osseous implant
Drill 3,75-4,25 stop L13 mm
3,75 RCD Quattro profile drill
TC Fidelis 3x13 drill
Drill 3,3-3,4 stop L13 mm
Expanders tray
Long hex. imp. coping abutment Maxi Inhex + screw
Hex impr. coping Maxi Inhex +screw TCP
Hex Aesthetic Imp.cop. Std. Oss. +screw
Drill 3,75-4,25 stop L6 mm
Long hex. imp. coping abutment Std Inhex + screw
Long Mini Osseous remover
3 RCD long helix drill l. 21 mm 6mm mark
Stoppers tray
Hex impr. coping Mini Oss. +screw
Maxi Inhex Long implant mount 20 mm w/s
Std depth gauge 6 mm depth mark
4,85 profile Inhex drill
Implant Analogue for Maxi Osseous
Modular Surgical Container Box Medium
3,3 RCD long helix drill l. 21 mm 6mm mark
3,3 Expander 6mm mark
3,3 mm concave sinus lift osteotome
Explantation screw for Mini Inhex implant
Hex long impr. coping Maxi Inhex +screw
Osseous Fidelis mount drive
3,3 RCD Quattro profile drill
Subcrestal profile drill 3.4-3.7 mm Platform
TC Fidelis 3,3x10 drill
Std Inhex remover
3,8 mm concave angled sinus lift osteotome
Long Hex. C/a 1.25 screwdriver l. 14 mm
4,7 RCD long helix drill l. 21 mm 6mm mark
3,6 profile Inhex drill
Hex Impresion coping Inhex Mini + screw TCP
1.25 Hex. screwdr. for 7mm. dia. ratchet l. 8 mm
2 Expander 6 mm mark
Std Inhex Long implant mount 20 mm w/s
4 helix hard bones drill l. 16 mm RCD 6mm mark
TC Fidelis 2x13 drill
Drill 5 stop L15 mm
Screw extraction wrench with rounded hex.
2,8 mm concave sinus lift osteotome
3,25 profile Inhex drill
3,3 RCD helix drill l. 16 mm 6mm mark
1/4 size tray
Long Std Osseous remover
Rot. Imp.cop. for 30º Tap.abut. Oss Maxi
Non hex impr. coping Mini Oss.
TC Fidelis 3,8x13 drill
TC Fidelis 3,3x13 drill
Analogue for Implant Std Inhex
Analogue for 10º Tap.abut. Maxi Oss
Os St-Mx PS/In St-Mx Digital Analogue 10º tapered abutment with screw
TC11 STD Inhex Direct Scanbody TCP with screw
Long hex. imp. coping abut Maxi Inhex + screw TCP
Broken screws ext. Os Mn-Os St-In St reamer
Drill extender
Drill 3,75-4,25 stop L9 mm
2,8 mm concave angled sinus lift osteotome
Fidelis tray
Drill 3,75-4,25 stop L11,5 mm
Inhex-Osseous Explantation Sheet
4,7 Expander 6mm mark
2 mm concave angled sinus lift osteotome
Inhex + Quattro Compact Tray
Implant Analogue for Std Osseous
Hex Impresion coping Inhex Std + screw TCP
Hex Impresion coping Inhex Std + screw
Extraoral screwdriver handle
7 mm dia. ratchet Long extender
5 Osseous/Inhex bone tap l. 16mm 6mm mark
Explantation tool for Std Osseous implant
TC1 MINI Osseous Direct Scanbody with screw
Os St-Mx PS/In St-Mx Digital Analogue 30º tapered abutment with screw
Osseous Maxi Digital Analogue 30º tapered abutment with screw
MINI Osseous Digital Analogue with screw
TC12 MAXI Inhex Direct Scanbody with screw
Broken prosthesis extraction wrench InHex Maxi
Long Hex. for c/a adapter
Explantation screw for Std Inhex implant
Short hex. imp. coping abut Mini Inhex + screw TCP
Drill 5 stop L11,5 mm
Explantation screw for Maxi Osseous implant
STD Inhex Digital Analogue with screw
MINI Inhex Digital Analogue with screw
3,8 mm angled expander osteotome
Long hex. imp. coping abutment Mini Inhex + screw
Prosthodontics tray
Maxi Osseous Long implant mount 20 mm w/s
Rot.Imp.cop. for 30º Tap.abut. Oss Maxi +screw
Std Osseous Long implant mount 20 mm w/s
Explantation tray
Long Mini Inhex remover
TC11 STD Inhex Direct Scanbody with screw
7mm dia.10-40Ncm adjustable torque wrench
Long Maxi Inhex remover
Plus Compact tray
Short hex. imp. coping abut Std Inhex + screw TCP
4,1 profile Inhex drill
Long hex. imp. coping abut Mini Inhex + screw TCP
2,8 mm straight expander osteotome
3,8 Expander 6mm laser mark
Rot.Imp.cop. 30ºTap.ab.Std Oss Inh.Std/Max +screw
Short Hex Ratchet Torque Screwdriver
Drill 3,3-3,4 stop L15 mm
Rot.Imp.cop.for 30º Tap.abut. Std. Oss Std/Maxi In
Analogue for 30º Tap.abut. Maxi Oss
Mini Osseous Long implant mount 20 mm w/s
Drill 5 stop L8 mm
Drill 3,3-3,4 stop L8 mm
TC6 Scanbody Inhex STD/Maxi - Oss STD Multiunit with screw
3,8 RCD long helix drill l. 21 mm 6mm mark
Broken screws ext. Os Mx-In Mx reamer
3,8 mm straight expander osteotome
Drill 5 stop L10 mm
Non hex impr. coping Maxi Inhex
Maxi depth gauge 6 mm depth mark
Maxi paralelling Pin
Counterwise tool for Os Mx-In Mn
Rot. Imp.cop. for 10º Tap.abut. Oss/Inh
Rot. Imp.cop. for 10º Tap.abut. Oss/Inh +screw
Short hex. imp. coping abutment Mini Inhex + screw
Explantation tool for Maxi Osseous implant
Implant Analogue for Mini Osseous
TC Fidelis 3,8x8 drill
Non hex Aesthetic impr. coping Std. Inhex
Maxi Inhex remover
Drill 3,75-4,25 stop L15 mm
Mount drive exchange holder
Long Std Inhex remover
Hex. dynamometric ratchet adapter
Hex impr. coping Std. Oss. +screw
Mini Osseous remover
Explantation screw for Mini-Std Osseous implant
TC3 Std/Maxi PS Osseous Direct Scanbody with screw
Straight pin setting instrument
Analog 10º tap abut Os Std-Maxi PS/In Std-Max
3,3 mm concave angled sinus lift osteotome
Short hex. imp. coping abutment Maxi Inhex + screw
Dynamometric removable ratchet wrench 250 Ncm
Hex long impr. coping Mini Oss. +screw
5 crestal bone profile drill
2 mm straight expander osteotome
3,3 mm angled expander osteotome
Hex Aesthetic impr. coping Std. Oss. +screw
3,2 helix hard bones drill l. 16 mm RCD 6mm mark
TC Fidelis 3x8 drill
Hex. for c/a adapter
Long Maxi Osseous remover
Pin fix Fidelis
Short hex. imp. coping abut Maxi Inhex + screw TCP
Fidelis Plus tray
Membranes tray
Explantation tool for Maxi Inhex implant
TC Fidelis 3,8x11,5 drill
1.25 Hex. screwdr. for 7mm. dia. ratchet l. 25 mm
Mini Inhex Long implant mount 20 mm w/s
Explantation tool for 3,75 Std Inhex implant
Analogue for Implant Mini Inhex
Long Hex C/a Torque Screwdriver
TC Fidelis 3x10 drill
Hex Aesthetic impr. coping Maxi Oss. +screw
Hex impr. coping Maxi Inhex +screw
Std Osseous remover
TC Fidelis 3,8x10 drill
C/a Fidelis 4 punch
2 RCD helix drill l. 16 mm 6mm mark
1 Dia. square C/a screwdriver L10 mm
3,3 mm straight expander osteotome
Temporary storage tray
2 RCD initial drill l. 13 mm 6 mm mark
Hex Aesthetic Imp coping Std Inhex +screw
3,3-3,4 Osseous/Inhex bone tap l. 16mm 6mm mark
Drill 3,3-3,4 stop L10 mm
Analogue for Multiunit abut
4,1 Osseous countersink
7 mm dia. ratchet Short extender
Drill 5 stop L9 mm
Tightening tool for explantation screw
Impression coping for Multiunit
3 Expander 6mm mark
3,8 mm concave sinus lift osteotome
Non hex long impr. coping Std. Inhex
Impr. coping for 10º Tap.abut. Oss/Inh +screw
Non hex impr. coping Maxi Oss.
Flat C/a screwdriver l. 14 mm
4,3 Expander 6mm mark
Modular Surgical Container Box
TC2 Scanbody 10º Tap. Ab. Oss/Inhex Mini
TC Fidelis pilot drill
3 RCD helix drill l. 16 mm 6mm mark
Long hex. imp. coping abut Std Inhex + screw TCP
Analogue for 10º Tap.abut. Mini Oss/Inh
4,7 RCD helix drill l. 16 mm 6mm mark
TC4 Scanbody 10º Tap. Ab. Os St/Mx PS-In St/Mx with screw
TC12 MAXI Inhex Direct Scanbody TCP with screw
Osseous Maxi Digital Analogue 10º tapered abutment with screw
TC7 MAXI Osseous Direct Scanbody with screw
MAXI Inhex Digital Analogue with screw
TC9 Scanbody 30º Tap. Ab. Osseous Maxi with screw
TC10 MINI Inhex Direct Scanbody TCP with screw
Osseous Std Digital Analogue with screw
Digital Analogue multiunit abutment with screw
TC10 MINI Inhex Direct Scanbody with screw
Basic Stoppers tray
TC5 Scanb. 30º Tap. Ab. Os St/Mx PS-In St/Mx with screw
Osseous-Inhex Mini Digital Analogue 10º tapered abutment with screw
MAXI Osseous Digital Analogue with screw
TC8 Scanbody 10º Tap. Ab. Osseous Maxi with screw
Surgical Fidelis guide tube
0.7 Dia. L9 mm Drill
TC Fidelis 3,3 Quattro profile drill
TC Fidelis 4,0x11 drill
TC Fidelis 4,0x13 drill
TC Fidelis 4,25 Quattro profile drill
TC Fidelis 3,5x8 drill
TC Fidelis 3,2x8 drill
TC Fidelis 3,2x10 drill
TC Fidelis 3,2x13 drill
TC Fidelis 3,5x13 drill
TC Fidelis 4,0x8 drill
Fidelis Crestal Drill
TC Fidelis 3,75 Quattro profile drill
TC Fidelis 4,0x10 drill
TC Fidelis 3,5x11 drill
TC Fidelis 3,2x11 drill
TC Fidelis 3,5x10 drill
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device