MOZO-GRAU SA

FDA Device Registration & Listing · Valladolid, ES · Registration 3031553803

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3031553803
FEI Number
3031553803
Entity Name
MOZO-GRAU SA
City/State/Country
Valladolid, ES
Establishment Address
Santiago Lopez Gonzalez 7, Valladolid 47197, ES
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device
Owner / Operator
MOZO-GRAU SA (Owner Number: 10090922)
Owner / Operator Contact Address
Santiago Lopez Gonzalez 7, Valladolid, ES-VA 47197, ES
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2024-06-03
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2024-06-03
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2024-07-08

Official Correspondent

Beatriz Santos

US Agent Details

Victor Sanchez Altura Business: PHARMA-BIO SERV, INC. Email: usagent@pbsvinc.com Phone: (787) 5072911

Related Public Records

Same Entity

MOZO-GRAU SA
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K081806 Idi Biomedical, LLC IDI IMPLANT SYSTEM 2008-11-07
K120793 Z-Systems AG Z-LOOK3 EVO SLM 2012-12-21
K130140 Intra-Lock International INTRA-LOCK OP DENTAL IMPLANT 2013-08-01
K925778 Nobelpharma USA, Inc. BRANEMARK SYSTEM LAB. AND EDUCATIONAL ACCESSORIES 1993-04-14
K903999 O Co., Inc. OBUTMENT HB 1992-02-11

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0010-2020 Implant Direct Sybron Manufacturing, LLC 2
ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Z-0017-2026 S.I.N. Implant System Ltda Rua Soldador Ocimar Guimaraes da Silva 421 Jardim Analia Franco Sao Paulo Brazil 2
IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N; IMPLANT EPIKUT PLUS MT16 3,5X15,0MM, REF: ILM 3515N; IMPLANT EPIKUT PLUS MT16 3,8X10,0MM, REF: ILM 3810N; IMPLANT CM16 3,8 X 11MM, REF: ILM 3811N; IMPLANT EPIKUT PLUS MT16 3,8X15,0MM, REF: ILM 3815N; IMPLANT EPIKUT PLUS MT16 4,0X10,0MM, REF: ILM 4010N; IMPLANT EPIKUT PLUS MT16 4,0X11,5MM, REF: ILM 4011N; IMPLANT EPIKUT PLUS MT16 4,0X13,0MM, REF: ILM 4013N; IMP EPIKUT PLUS LONG MT16 4,0X20,0MM, RES: ILM 4020N; IMPLANT EPIKUT PLUS MT16 4,0X8,5MM, RES: ILM 4085N; IMPLANT EPIKUT PLUS MT16 4,5X13,0MM, REF: ILM 4513N; IMPLANT EPIKUT PLUS MT16 4,5X15,0MM, REF: ILM 4515N; IMPLANT EPIKUT PLUS MT16 4,5X8,5MM, REF: ILM 4585N; IMPLANT EPIKUT PLUS MT16 5,0X10,0MM, REF: ILM 5010N; IMPLANT EPIKUT PLUS MT16 5,0X11,5MM, REF: ILM 5011N; IMPLANT EPIKUT PLUS MT16 4,5X10,0MM, REF: ILM 4510N; IMPLANT EPIKUT PLUS MT16 5,0X13,0MM, RES: ILM 5013N; IMPLANT EPIKUT PLUS MT16 5,0X15,0MM, REF: ILM 5015N; IMPLANT EPIKUT PLUS MT16 5,0X8,5MM, REF: ILM 5085N; IMP EPIKUT PLUS LONG MT16 4,0X18,0MM, REF: ILM 4018N; IMP EPIKUT PLUS LONG MT16 3,8X18,0MM, REF: ILM 3818N; IMPLANT EPIKUT PLUS MT16 4,5X11,5MM, REF: ILM 4511N; IMPLANT EPIKUT MT16 4,5X15,0MM, REF: ILM 4515; IMPLANT EPIKUT MT16 4,5X8,5MM, REF: ILM 4585; IMPLANT EPIKUT MT16 3,8X13,0MM, REF: ILM 3813; IMPLANT EPIKUT MT16 3,8X15,0MM, REF: ILM 3815; IMPLANT EPIKUT MT16 5,0X8,5MM, REF: ILM 5085; IMPLANT EPIKUT MT16 3,8X11,5MM, REF: ILM 3811; IMPLANT EPIKUT PLUS MT16 3,8X20,0MM, REF: ILM 3820N; IMPLANT EPIKUT PLUS MT16 4,5X18,0MM, REF: ILM 4518N; IMPLANT UNITITE MORSE COMPACT 6.0X7MM, REF: UCMC 6007N
Z-0018-2020 Implant Direct Sybron Manufacturing, LLC 2
ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Z-0019-2020 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 2
Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P
Z-0029-05 Implant Innovations, Inc. 2
EP Healing Abutment- An abutment device is a premanufactured prosthetic component directly connected to the endosseous dental implant.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031553803. Last updated year: 2026. Please use registration number 3031553803 when referencing this establishment in official correspondence.
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