FDA Registration
Active
🇪🇸 Spain
MAXI Osseous Digital Analogue with screw
Reg #: 3031553803
·
FEI: 3031553803
·
Expires 2025
Products
1
Proprietary Names
271
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- MOZO-GRAU SA
- Registration Number
- 3031553803
- FEI Number
- 3031553803
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Santiago Lopez Gonzalez 7
- City
- Valladolid
- Country
- ES
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 |
|---|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2024-07-08 |
Proprietary Names
MAXI Osseous Digital Analogue with screw
STD Inhex Digital Analogue with screw
TC2 Scanbody 10º Tap. Ab. Oss/Inhex Mini
TC11 STD Inhex Direct Scanbody with screw
7mm dia.10-40Ncm adjustable torque wrench
TC Fidelis 3x13 drill
Short hex. imp. coping abut Std Inhex + screw TCP
Long hex. imp. coping abut Mini Inhex + screw TCP
2,8 mm straight expander osteotome
Hex impr. coping Maxi Inhex +screw TCP
Broken prosthesis extraction wrench InHex Mini/Std
3,75 RCD Quattro profile drill
Plus Compact tray
Counterwise tool for Os Mn-Os St-In Mx
Drill 3,3-3,4 stop L13 mm
Expanders tray
Short hex. imp. coping abutment Std Inhex + screw
Long hex. imp. coping abutment Maxi Inhex + screw
Short Hex Ratchet Torque Screwdriver
TC Fidelis pilot drill
3 RCD helix drill l. 16 mm 6mm mark
Maxi Inhex remover
Rot.Imp.cop.for 30º Tap.abut. Std. Oss Std/Maxi In
Mount drive exchange holder
Drill 5 stop L8 mm
3,3 Expander 6mm mark
2 mm angled expander osteotome
Explantation screw for Mini Inhex implant
Osseous Fidelis mount drive
3,3 RCD Quattro profile drill
Hex impr. coping Mini Inhex +screw
Mini Inhex Long implant mount 20 mm w/s
Explantation tool for 3,75 Std Inhex implant
Analogue for Implant Mini Inhex
4,7 Expander 6mm mark
Long Hex C/a Torque Screwdriver
Inhex + Quattro Compact Tray
Implant Analogue for Std Osseous
3,8 RCD long helix drill l. 21 mm 6mm mark
3,8 mm angled expander osteotome
Drill 5 stop L10 mm
Maxi depth gauge 6 mm depth mark
Drill 3,75-4,25 stop L8 mm
Maxi paralelling Pin
Long Maxi Inhex remover
Hex Aesthetic Imp.cop. Std. Oss. +screw
4,1 profile Inhex drill
3,8 Expander 6mm laser mark
Drill 3,75-4,25 stop L9 mm
Rot.Imp.cop. 30ºTap.ab.Std Oss Inh.Std/Max +screw
Std Inhex remover
Maxi Inhex Long implant mount 20 mm w/s
Std depth gauge 6 mm depth mark
3,8 mm concave angled sinus lift osteotome
4,85 profile Inhex drill
Dynamometric removable ratchet wrench 250 Ncm
4,7 RCD long helix drill l. 21 mm 6mm mark
Modular Surgical Container Box Medium
Explantation tool for 4,25 Std Inhex implant
2,8 mm concave sinus lift osteotome
Hex Aesthetic impr. coping Std. Oss. +screw
4,3 RCD long helix drill l. 21 mm 6mm mark
4,9 helix hard bones drill l. 16 mm RCD 6mm mark
4,25 RCD Quattro profile drill
Drill 3,3-3,4 stop L10 mm
Counterwise tool for In St
4,1 Osseous countersink
4,25 Osseous/Inhex bone tap l. 16mm 6mm mark
Tightening tool for explantation screw
Drill 3,3-3,4 stop L6 mm
3 Expander 6mm mark
Maxi Osseous remover
4.1 Fidelis Oss countersink l.11.50 mm
Drill 5 stop L9 mm
2,8 mm angled expander osteotome
Impression coping for Multiunit
Rot. Imp.cop. for 10º Tap.abut. Max Oss/Inh
Hex impr. coping Maxi Oss. +screw
3,8 mm concave sinus lift osteotome
Long hex. imp. coping abut Std Inhex + screw TCP
3,2 helix hard bones drill l. 16 mm RCD 6mm mark
Analogue for 10º Tap.abut. Mini Oss/Inh
Multiconverter
Long Std Inhex remover
Long Maxi Osseous remover
Hex. dynamometric ratchet adapter
Short hex. imp. coping abut Maxi Inhex + screw TCP
4,7 RCD helix drill l. 16 mm 6mm mark
Mini Osseous remover
4,3 RCD helix drill l. 16 mm 6mm mark
Explantation tool for Maxi Inhex implant
Implant insertion tool
Explantation screw for Maxi Inhex implant
TC Fidelis 2x10 drill
Osseous-Inhex + Quattro Compact Tray
Drill 5 stop L6 mm
Non hex long impr. coping Std. Inhex
TC Fidelis 3,3x8 drill
Non hex impr. coping Maxi Oss.
Non hex Aesthetic impr. coping Maxi Inhex
4,3 Expander 6mm mark
1.25 Hex. screwdr. for 7mm. dia. ratchet l. 8 mm
Hex Impresion coping Inhex Std + screw TCP
Hex Impresion coping Inhex Std + screw
Std Inhex Long implant mount 20 mm w/s
Extraoral screwdriver handle
TC Fidelis 2x13 drill
5 Osseous/Inhex bone tap l. 16mm 6mm mark
Short Hex C/a Torque Screwdriver
TC Fidelis 3,8x11,5 drill
1.25 Hex. screwdr. for 7mm. dia. ratchet l. 25 mm
Hex long impr. coping Std. Inhex +screw
Inhex-Osseous Explantation Sheet
3,8 RCD helix drill l. 16 mm 6mm mark
Rot. Imp.cop. for 10º Tap.abut. Oss/Inh
3,3 mm straight expander osteotome
Drill 5 stop L13 mm
Short hex. imp. coping abutment Mini Inhex + screw
Mini Inhex remover
Implant Analogue for Mini Osseous
Hex Aesthetic Imp coping Std Inhex +screw
Fidelis tray
Analogue for Implant Maxi Inhex
RCD Quattro guiding drill diameter 3
Analogue for Multiunit abut
Drill 3,75-4,25 stop L11,5 mm
2 initial drill l. 13 mm 6 mm mark
7 mm dia. ratchet Short extender
2 mm concave angled sinus lift osteotome
Osseous Std Digital Analogue with screw
3,25 profile Inhex drill
3,3 RCD helix drill l. 16 mm 6mm mark
1/4 size tray
TC Fidelis 3x8 drill
Hex. for c/a adapter
Ratchet wrench 7mm dia
Long Std Osseous remover
Pin fix Fidelis
Rot. Imp.cop. for 10º Tap.abut. Oss/Inh Maxi+screw
Digital Analogue multiunit abutment with screw
Counterwise tool for Os Mx-In Mn
Short hex. imp. coping abutment Maxi Inhex + screw
Rot. Imp.cop. for 10º Tap.abut. Oss/Inh +screw
5 crestal bone profile drill
Explantation tool for Maxi Osseous implant
3,3 mm angled expander osteotome
TC Fidelis 3,8x8 drill
Broken prosthesis extraction wrench InHex Maxi
Drill 3,3-3,4 stop L11,5 mm
Long hex. imp. coping abutment Std Inhex + screw
Stoppers tray
Hex impr. coping Mini Oss. +screw
3,3 mm concave sinus lift osteotome
Broken screws ext. Os Mx-In Mx reamer
Hex long impr. coping Maxi Inhex +screw
Flat screwdriver ratchet for 7mm l. 14 mm
Subcrestal profile drill 3.4-3.7 mm Platform
Osseous-Inhex 1/2 Quattro tray
Osseous Maxi Digital Analogue 10º tapered abutment with screw
TC7 MAXI Osseous Direct Scanbody with screw
TC1 MINI Osseous Direct Scanbody with screw
MINI Inhex Digital Analogue with screw
TC3 Std/Maxi PS Osseous Direct Scanbody with screw
TC10 MINI Inhex Direct Scanbody TCP with screw
TC6 Scanbody Inhex STD/Maxi - Oss STD Multiunit with screw
TC5 Scanb. 30º Tap. Ab. Os St/Mx PS-In St/Mx with screw
Osseous Maxi Digital Analogue 30º tapered abutment with screw
Long Hex Ratchet Torque Screwdriver
2 Expander 6 mm mark
Non hex long impr. coping Maxi Inhex
Std paralelling Pin
Drill 3,75-4,25 stop L13 mm
Drill 5 stop L15 mm
Screw extraction wrench with rounded hex.
MAXI Inhex Digital Analogue with screw
MINI Osseous Digital Analogue with screw
Maxi Osseous Long implant mount 20 mm w/s
Std Osseous Long implant mount 20 mm w/s
Explantation tray
Long Mini Inhex remover
3,6 profile Inhex drill
Hex Impresion coping Inhex Mini + screw TCP
Long hex. imp. coping abut Maxi Inhex + screw TCP
Broken screws ext. Os Mn-Os St-In St reamer
Drill 3,75-4,25 stop L6 mm
Drill extender
Long Mini Osseous remover
3 RCD long helix drill l. 21 mm 6mm mark
Short hex. imp. coping abut Mini Inhex + screw TCP
2,8 mm concave angled sinus lift osteotome
Explantation screw for Maxi Osseous implant
TC12 MAXI Inhex Direct Scanbody with screw
TC4 Scanbody 10º Tap. Ab. Os St/Mx PS-In St/Mx with screw
TC8 Scanbody 10º Tap. Ab. Osseous Maxi with screw
TC11 STD Inhex Direct Scanbody TCP with screw
Non hex impr. coping Mini Oss.
TC Fidelis 3,8x13 drill
Analogue for Implant Std Inhex
1.25 Hex. screwdr. for 7mm. dia. ratchet l. 14 mm
Hex Aesthetic impr. coping Maxi Inhex +screw
Analogue for 10º Tap.abut. Maxi Oss
Drill 3,3-3,4 stop L9 mm
TC Fidelis 3,3x10 drill
TC9 Scanbody 30º Tap. Ab. Osseous Maxi with screw
Analog 30º tap abut Os Std-Maxi PS/In Std-Max
Non hex impr. coping Std. Inhex
3,8 mm straight expander osteotome
3,75 Osseous/Inhex bone tap l. 16mm 6mm mark
Non hex impr. coping Maxi Inhex
Explantation tool for Mini Inhex implant
TC Fidelis 3x11,5 drill
2 mm concave sinus lift osteotome
Hex impr. coping Maxi Inhex +screw
Drill 3,3-3,4 stop L15 mm
Std Osseous remover
TC Fidelis 3,8x10 drill
Mini Osseous Long implant mount 20 mm w/s
2 RCD helix drill l. 16 mm 6mm mark
Drill 3,3-3,4 stop L8 mm
Long Hex. for c/a adapter
TC Fidelis 2x11,5 drill
Explantation screw for Std Inhex implant
Non hex Aesthetic impr. coping Std. Oss.
4 helix hard bones drill l. 16 mm RCD 6mm mark
Drill 5 stop L11,5 mm
Explantation tool for Mini Osseous implant
Temporary storage tray
TC Fidelis 3,3x11,5 drill
2 RCD initial drill l. 13 mm 6 mm mark
Fidelis 6mm long drill
Drill 3,75-4,25 stop L10 mm
3,3-3,4 Osseous/Inhex bone tap l. 16mm 6mm mark
Impr. coping for 10º Tap.abut. Oss/Inh +screw
Non hex impr. coping Std. Oss. w/s
Flat C/a screwdriver l. 14 mm
20 long helix drill 6 mm depth mark l. 21 mm
Inhex Fidelis mount drive
Modular Surgical Container Box
Broken screws ext. In Mn reamer
3,5 helix hard bones drill l. 16 mm RCD 6mm mark
Analog 10º tap abut Os Std-Maxi PS/In Std-Max
3,3 mm concave angled sinus lift osteotome
Implant Analogue for Maxi Osseous
Hex long impr. coping Mini Oss. +screw
3,3 RCD long helix drill l. 21 mm 6mm mark
2 mm straight expander osteotome
Non hex Aesthetic impr. coping Std. Inhex
Rot. Imp.cop. for 30º Tap.abut. Oss Maxi
Mini depth gauge 6 mm depth mark
Drill 3,75-4,25 stop L15 mm
TC Fidelis 3,3x13 drill
Hex impr. coping Std. Oss. +screw
Explantation screw for Mini-Std Osseous implant
Os St-Mx PS/In St-Mx Digital Analogue 10º tapered abutment with screw
Subcrestal profile drill 4,1-4,5 mm Platform
Long hex. imp. coping abutment Mini Inhex + screw
Prosthodontics tray
Short Hex. C/a 1.25 screwdriver l. 9 mm
Rot.Imp.cop. for 30º Tap.abut. Oss Maxi +screw
Long Hex. C/a 1.25 screwdriver l. 14 mm
Mini paralelling Pin
Os St-Mx PS/In St-Mx Digital Analogue 30º tapered abutment with screw
TC12 MAXI Inhex Direct Scanbody TCP with screw
TC Fidelis 3x10 drill
Hex Aesthetic impr. coping Maxi Oss. +screw
7 mm dia. ratchet Long extender
Analogue for 30º Tap.abut. Maxi Oss
Explantation tool for Std Osseous implant
C/a Fidelis 4 punch
TC10 MINI Inhex Direct Scanbody with screw
Osseous-Inhex Mini Digital Analogue 10º tapered abutment with screw
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device