Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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A driver for a dental torque wrench for placement and adjustment of dental implants, abutments, abutment screw and prosthetic screws during oral surgery and prosthetic procedures.
Elos Medtech Pinol A/S
ISOHEXADPT
In Commercial Distribution

  • 05712821012906 ()
  • 05712821012913 ()
ISOHEXADPT

  • Surgical torque wrench adaptor
The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the patient’s jawbone. The Scan Body is intended to be attached to the implant/abutment directly in the patients’ mouth when using an intra-oral scanner. It is manufactured from biocompatible titanium alloy (TiAl6V4 ELI). The Scan Body Driver that is provided separately, is used to fasten the Scan Body to the Implant.
Elos Medtech Pinol A/S
SB-SBX45-1
In Commercial Distribution

  • 05712821012876 ()
  • 05712821012883 ()
SB-SBX45-1

  • Dental implant suprastructure, temporary, preformed, reusable
The Scan Body is manufactured from biocompatible titanium alloy (TiAl6V4 ELI) and polyetheretherketone (PEEK). The corresponding Scan Body Driver used to tighten the integrated screw is manufactured from biocompatible stainless steel. The product is available for a variety of implant platforms. For specific product descriptions, please refer to individual product labels.
Elos Medtech Pinol A/S
IO 13A-A
In Commercial Distribution

  • 05712821010636 ()
  • 05712821010674 ()
IO 13A-A

  • Dental implant suprastructure, temporary, preformed, reusable
The Scan Body is manufactured from biocompatible titanium alloy (TiAl6V4 ELI) and polyetheretherketone (PEEK). The corresponding Scan Body Driver used to tighten the integrated screw is manufactured from biocompatible stainless steel. The product is available for a variety of implant platforms. For specific product descriptions, please refer to individual product labels.
Elos Medtech Pinol A/S
IO 12A-A
In Commercial Distribution

  • 05712821010612 ()
  • 05712821010650 ()
IO 12A-A

  • Dental implant suprastructure, temporary, preformed, reusable
The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the final prosthetic restoration to the implant. The Prosthetic Screws have a hexalobular driver connection interface.
Elos Medtech Pinol A/S
AS-NGMM1610A-1
In Commercial Distribution

  • 05712821010544 ()
AS-NGMM1610A-1

  • Dental prosthesis/implant abutment screw
The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the final prosthetic restoration to the implant. The Prosthetic Screws have a hexalobular driver connection interface.
Elos Medtech Pinol A/S
AS-HETM2008A-1
In Commercial Distribution

  • 05712821010537 ()
AS-HETM2008A-1

  • Dental prosthesis/implant abutment screw
The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the patient’s jawbone. The Scan Body is intended to be attached to the implant/abutment directly in the patients’ mouth when using an intra-oral scanner. It is manufactured from biocompatible titanium alloy (TiAl6V4 ELI). The Scan Body Driver that is provided separately, is used to fasten the Scan Body to the Implant.
Elos Medtech Pinol A/S
68020522
In Commercial Distribution

  • 05712821014665 ()
68020522

  • Dental implant suprastructure, temporary, preformed, reusable
The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the patient’s jawbone. The Scan Body is intended to be attached to the implant/abutment directly in the patients’ mouth when using an intra-oral scanner. It is manufactured from biocompatible titanium alloy (TiAl6V4 ELI). The Scan Body Driver that is provided separately, is used to fasten the Scan Body to the Implant.
Elos Medtech Pinol A/S
68020521
In Commercial Distribution

  • 05712821014658 ()
68020521

  • Dental implant suprastructure, temporary, preformed, reusable
The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the patient’s jawbone. The Scan Body is intended to be attached to the implant/abutment directly in the patients’ mouth when using an intra-oral scanner. It is manufactured from biocompatible titanium alloy (TiAl6V4 ELI). The Scan Body Driver that is provided separately, is used to fasten the Scan Body to the Implant.
Elos Medtech Pinol A/S
68020520
In Commercial Distribution

  • 05712821014641 ()
68020520

  • Dental implant suprastructure, temporary, preformed, reusable
The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the patient’s jawbone. The Scan Body is intended to be attached to the implant/abutment directly in the patients’ mouth when using an intra-oral scanner. It is manufactured from biocompatible titanium alloy (TiAl6V4 ELI). The Scan Body Driver that is provided separately, is used to fasten the Scan Body to the Implant.
Elos Medtech Pinol A/S
68020519
In Commercial Distribution

  • 05712821014634 ()
68020519

  • Dental implant suprastructure, temporary, preformed, reusable
The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the patient’s jawbone. The Scan Body is intended to be attached to the implant/abutment directly in the patients’ mouth when using an intra-oral scanner. It is manufactured from biocompatible titanium alloy (TiAl6V4 ELI). The Scan Body Driver that is provided separately, is used to fasten the Scan Body to the Implant.
Elos Medtech Pinol A/S
68020518
In Commercial Distribution

  • 05712821014627 ()
68020518

  • Dental implant suprastructure, temporary, preformed, reusable
The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the patient’s jawbone. The Scan Body is intended to be attached to the implant/abutment directly in the patients’ mouth when using an intra-oral scanner. It is manufactured from biocompatible titanium alloy (TiAl6V4 ELI). The Scan Body Driver that is provided separately, is used to fasten the Scan Body to the Implant.
Elos Medtech Pinol A/S
68020517
In Commercial Distribution

  • 05712821014610 ()
68020517

  • Dental implant suprastructure, temporary, preformed, reusable
The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the patient’s jawbone. The Scan Body is intended to be attached to the implant/abutment directly in the patients’ mouth when using an intra-oral scanner. It is manufactured from biocompatible titanium alloy (TiAl6V4 ELI). The Scan Body Driver that is provided separately, is used to fasten the Scan Body to the Implant.
Elos Medtech Pinol A/S
XNAC40
In Commercial Distribution

  • 05712821014061 ()
  • 05712821014085 ()
XNAC40

  • Dental implant suprastructure, temporary, preformed, reusable
The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the patient’s jawbone. The Scan Body is intended to be attached to the implant/abutment directly in the patients’ mouth when using an intra-oral scanner. It is manufactured from biocompatible titanium alloy (TiAl6V4 ELI). The Scan Body Driver that is provided separately, is used to fasten the Scan Body to the Implant.
Elos Medtech Pinol A/S
XDBA40
In Commercial Distribution

  • 05712821014054 ()
  • 05712821014078 ()
XDBA40

  • Dental implant suprastructure, temporary, preformed, reusable
The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the patient’s jawbone. The Scan Body is intended to be attached to the implant/abutment directly in the patients’ mouth when using an intra-oral scanner. It is manufactured from biocompatible titanium alloy (TiAl6V4 ELI). The Scan Body Driver that is provided separately, is used to fasten the Scan Body to the Implant.
Elos Medtech Pinol A/S
XNGA35
In Commercial Distribution

  • 05712821013972 ()
  • 05712821014047 ()
XNGA35

  • Dental implant suprastructure, temporary, preformed, reusable
The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the patient’s jawbone. The Scan Body is intended to be attached to the implant/abutment directly in the patients’ mouth when using an intra-oral scanner. It is manufactured from biocompatible titanium alloy (TiAl6V4 ELI). The Scan Body Driver that is provided separately, is used to fasten the Scan Body to the Implant.
Elos Medtech Pinol A/S
XCBA43
In Commercial Distribution

  • 05712821013965 ()
  • 05712821014030 ()
XCBA43

  • Dental implant suprastructure, temporary, preformed, reusable
The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the patient’s jawbone. The Scan Body is intended to be attached to the implant/abutment directly in the patients’ mouth when using an intra-oral scanner. It is manufactured from biocompatible titanium alloy (TiAl6V4 ELI). The Scan Body Driver that is provided separately, is used to fasten the Scan Body to the Implant.
Elos Medtech Pinol A/S
XATU45
In Commercial Distribution

  • 05712821013958 ()
  • 05712821014023 ()
XATU45

  • Dental implant suprastructure, temporary, preformed, reusable
The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the patient’s jawbone. The Scan Body is intended to be attached to the implant/abutment directly in the patients’ mouth when using an intra-oral scanner. It is manufactured from biocompatible titanium alloy (TiAl6V4 ELI). The Scan Body Driver that is provided separately, is used to fasten the Scan Body to the Implant.
Elos Medtech Pinol A/S
XATU20
In Commercial Distribution

  • 05712821013941 ()
  • 05712821014016 ()
XATU20

  • Dental implant suprastructure, temporary, preformed, reusable
The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the patient’s jawbone. The Scan Body is intended to be attached to the implant/abutment directly in the patients’ mouth when using an intra-oral scanner. It is manufactured from biocompatible titanium alloy (TiAl6V4 ELI). The Scan Body Driver that is provided separately, is used to fasten the Scan Body to the Implant.
Elos Medtech Pinol A/S
XAUE33
In Commercial Distribution

  • 05712821013934 ()
  • 05712821014009 ()
XAUE33

  • Dental implant suprastructure, temporary, preformed, reusable
The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the patient’s jawbone. The Scan Body is intended to be attached to the implant/abutment directly in the patients’ mouth when using an intra-oral scanner. It is manufactured from biocompatible titanium alloy (TiAl6V4 ELI). The Scan Body Driver that is provided separately, is used to fasten the Scan Body to the Implant.
Elos Medtech Pinol A/S
XSSA46
In Commercial Distribution

  • 05712821013927 ()
  • 05712821013996 ()
XSSA46

  • Dental implant suprastructure, temporary, preformed, reusable
The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the patient’s jawbone. The Scan Body is intended to be attached to the implant/abutment directly in the patients’ mouth when using an intra-oral scanner. It is manufactured from biocompatible titanium alloy (TiAl6V4 ELI). The Scan Body Driver that is provided separately, is used to fasten the Scan Body to the Implant.
Elos Medtech Pinol A/S
XSSA35
In Commercial Distribution

  • 05712821013910 ()
  • 05712821013989 ()
XSSA35

  • Dental implant suprastructure, temporary, preformed, reusable
The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the final prosthetic restoration to the implant. The Prosthetic Screws have a hexalobular driver connection interface.
Elos Medtech Pinol A/S
AS-BCEM1608NCA-1
In Commercial Distribution

  • 05712821013743 ()
AS-BCEM1608NCA-1

  • Dental prosthesis/implant abutment screw
The Glidewell Torque Wrench is made of lightweight titanium and stainless steel. The Torque Wrench & Driver product design, finish and quality make the tool well suited for placement and adjustment of implants, abutments and screws during surgery and other clinical procedures. The Torque Wrench & Driver is easy to prepare for cleaning, disinfection and sterilization. Exchangeable screwdrivers and the Driver make the tool compatible to various implant systems. The driver is available for a variety of connections. For specific product descriptions, please refer to individual product labels.
Elos Medtech Pinol A/S
70-C35120
In Commercial Distribution

  • 05712821013729 ()
  • 05712821013736 ()
70-C35120

  • Dental torque wrench
The Glidewell Torque Wrench is made of lightweight titanium and stainless steel. The Torque Wrench & Driver product design, finish and quality make the tool well suited for placement and adjustment of implants, abutments and screws during surgery and other clinical procedures. The Torque Wrench & Driver is easy to prepare for cleaning, disinfection and sterilization. Exchangeable screwdrivers and the Driver make the tool compatible to various implant systems. The driver is available for a variety of connections. For specific product descriptions, please refer to individual product labels.
Elos Medtech Pinol A/S
70-C35119
In Commercial Distribution

  • 05712821013712 ()
  • 05712821013736 ()
70-C35119

  • Dental torque wrench
The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the patient’s jawbone. The Scan Body is intended to be attached to the implant/abutment directly in the patients’ mouth when using an intra-oral scanner. It is manufactured from biocompatible titanium alloy (TiAl6V4 ELI). The Scan Body Driver that is provided separately, is used to fasten the Scan Body to the Implant.
Elos Medtech Pinol A/S
68020510
In Commercial Distribution

  • 05712821013705 ()
68020510

  • Dental implant suprastructure, temporary, preformed, reusable
The product consists of the Prosthetic Screwdriver which is manufactured from stainless steel. The product is available in different lengths. For specific product descriptions, please refer to individual product labels.
Elos Medtech Pinol A/S
68020509
In Commercial Distribution

  • 05712821013699 ()
68020509

  • Surgical screwdriver, reusable
The product consists of the Prosthetic Screwdriver which is manufactured from stainless steel. The product is available in different lengths. For specific product descriptions, please refer to individual product labels.
Elos Medtech Pinol A/S
68020508
In Commercial Distribution

  • 05712821013682 ()
68020508

  • Surgical screwdriver, reusable
The product consists of the Prosthetic Screwdriver which is manufactured from stainless steel. The product is available in different lengths. For specific product descriptions, please refer to individual product labels.
Elos Medtech Pinol A/S
68020507
In Commercial Distribution

  • 05712821013675 ()
68020507

  • Surgical screwdriver, reusable
The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the final prosthetic restoration to the implant. The Prosthetic Screws have a hexalobular driver connection interface.
Elos Medtech Pinol A/S
68020506
In Commercial Distribution

  • 05712821013668 ()
68020506

  • Dental prosthesis/implant abutment screw
The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the final prosthetic restoration to the implant. The Prosthetic Screws have a hexalobular driver connection interface.
Elos Medtech Pinol A/S
68020503
In Commercial Distribution

  • 05712821013651 ()
68020503

  • Dental prosthesis/implant abutment screw
No Description
SYNCARDIA SYSTEMS, LLC
297043-001
In Commercial Distribution

  • 00858000003237 ()


  • Ventricular prosthesis system, pneumatically-powered
No Description
SYNCARDIA SYSTEMS, LLC
297032-100
In Commercial Distribution

  • 00858000003206 ()


  • Ventricular prosthesis system, pneumatically-powered
No Description
SYNCARDIA SYSTEMS, LLC
397001-001
In Commercial Distribution

  • 00858000003145 ()


  • Ventricular prosthesis system, pneumatically-powered
No Description
SYNCARDIA SYSTEMS, LLC
595000-001
In Commercial Distribution

  • 00858000003121 ()
  • 10858000003128 ()


  • Ventricular prosthesis system, pneumatically-powered
No Description
SYNCARDIA SYSTEMS, LLC
397002-001
In Commercial Distribution

  • 00858000003107 ()


  • Ventricular prosthesis system, pneumatically-powered
No Description
FlexDex Surgical
8ND1L
In Commercial Distribution

  • 00860004002147 ()


  • Suturing needle holder, reusable
No Description
FlexDex Surgical
8ND1M
In Commercial Distribution

  • 00860004002130 ()


  • Suturing needle holder, reusable
No Description
FlexDex Surgical
FD-335 ND
Not in Commercial Distribution

  • 00860004002116 ()
  • 00860004002109 ()


  • Suturing needle holder, single-use
Insertion indicator
Oticon Medical AB
M52366
Not in Commercial Distribution

  • 05712149009909 ()
M52366

  • Surgical screwdriver, reusable
Abutment inserter, machine
Oticon Medical AB
M51695
In Commercial Distribution

  • 05712149005895 ()
M51695

  • Surgical screwdriver, reusable
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