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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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Elos Accurate® Scan Body - 05712821004871

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 3A-B
In Commercial Distribution

  • 05712821004871 ()
  • 05712821008688 ()
IO 3A-B

  • Dental implant suprastructure, temporary, preformed, reusable

Elos Accurate® Scan Body - 05712821004864

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 3A-A
In Commercial Distribution

  • 05712821004864 ()
  • 05712821008671 ()
IO 3A-A

  • Dental implant suprastructure, temporary, preformed, reusable

Elos Accurate® Scan Body - 05712821004857

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 2B-D
In Commercial Distribution

  • 05712821004857 ()
  • 05712821008572 ()
N/a

  • Dental implant suprastructure, temporary, preformed, reusable

Elos Accurate® Scan Body - 05712821004840

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 20A-A
In Commercial Distribution

  • 05712821004840 ()
  • 05712821009234 ()
N/a

  • Dental implant suprastructure, temporary, preformed, reusable

Elos Accurate® Scan Body - 05712821004833

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 1B-A
In Commercial Distribution

  • 05712821004833 ()
  • 05712821008527 ()
N/a

  • Dental implant suprastructure, temporary, preformed, reusable

Elos Accurate® Scan Body - 05712821004826

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 1A-B
In Commercial Distribution

  • 05712821004826 ()
  • 05712821008510 ()
N/a

  • Dental implant suprastructure, temporary, preformed, reusable

Elos Accurate® Scan Body - 05712821004819

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 1A-A
In Commercial Distribution

  • 05712821004819 ()
  • 05712821008503 ()
N/a

  • Dental implant suprastructure, temporary, preformed, reusable

Elos Accurate® Hexalobular Prosthetic Screw - 05712821002358

The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the final prosthetic restoration to the abutment. The Prosthetic Screws have a hexalobular driver connection interface.
Elos Medtech Pinol A/S
AS-CBAM1604A-1
In Commercial Distribution

  • 05712821002358 ()


  • Dental implant suprastructure, permanent, preformed

Elos Accurate® Hexalobular Prosthetic Screw - 05712821002341

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-ZSVM1808A-1
In Commercial Distribution

  • 05712821002341 ()
AS-ZSVM1808A-1

  • Dental prosthesis/implant abutment screw

Elos Accurate® Hexalobular Prosthetic Screw - 05712821002334

The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the final prosthetic restoration to the abutment. The Prosthetic Screws have a hexalobular driver connection interface.
Elos Medtech Pinol A/S
AS-ATUM1405A-1
In Commercial Distribution

  • 05712821002334 ()


  • Dental implant suprastructure, permanent, preformed

Elos Accurate® Hexalobular Prosthetic Screw - 05712821002327

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-NBRM2010A-1
In Commercial Distribution

  • 05712821002327 ()


  • Dental prosthesis/implant abutment screw

Elos Accurate® Hexalobular Prosthetic Screw - 05712821002310

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-NBRM1808A-1
In Commercial Distribution

  • 05712821002310 ()


  • Dental prosthesis/implant abutment screw

Elos Accurate® Hexalobular Prosthetic Screw - 05712821002303

The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the final prosthetic restoration to the abutment. The Prosthetic Screws have a hexalobular driver connection interface.
Elos Medtech Pinol A/S
AS-AUEM1805A-1
In Commercial Distribution

  • 05712821002303 ()


  • Dental implant suprastructure, permanent, preformed

Elos Accurate® Hexalobular Prosthetic Screw - 05712821002297

The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the final prosthetic restoration to the abutment. The Prosthetic Screws have a hexalobular driver connection interface.
Elos Medtech Pinol A/S
AS-DBAM1605A-1
In Commercial Distribution

  • 05712821002297 ()


  • Dental implant suprastructure, permanent, preformed

Elos Accurate® Hexalobular Prosthetic Screw - 05712821002280

The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the final prosthetic restoration to the abutment. The Prosthetic Screws have a hexalobular driver connection interface.
Elos Medtech Pinol A/S
AS-SSAM1404A-1
In Commercial Distribution

  • 05712821002280 ()


  • Dental implant suprastructure, permanent, preformed

Elos Accurate® Hexalobular Prosthetic Screw - 05712821002273

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-SSYM2007A-1
In Commercial Distribution

  • 05712821002273 ()
AS-SSYM2007A-1

  • Dental prosthesis/implant abutment screw

Elos Accurate® Hexalobular Prosthetic Screw - 05712821002266

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-SBOM1608A-1
In Commercial Distribution

  • 05712821002266 ()


  • Dental prosthesis/implant abutment screw

Elos Accurate® Hexalobular Prosthetic Screw - 05712821002228

The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the final prosthetic restoration to the abutment. The Prosthetic Screws have a hexalobular driver connection interface.
Elos Medtech Pinol A/S
AS-MUAM1804A-1
In Commercial Distribution

  • 05712821002228 ()


  • Dental implant suprastructure, permanent, preformed

Elos Accurate® Hexalobular Prosthetic Screw - 05712821002211

The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the final prosthetic restoration to the abutment. The Prosthetic Screws have a hexalobular driver connection interface.
Elos Medtech Pinol A/S
AS-MUAM1403A-1
In Commercial Distribution

  • 05712821002211 ()


  • Dental implant suprastructure, permanent, preformed

Elos Accurate® Hexalobular Prosthetic Screw - 05712821002204

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-NBAM2007A-1
In Commercial Distribution

  • 05712821002204 ()


  • Dental prosthesis/implant abutment screw

Elos Accurate® Hexalobular Prosthetic Screw - 05712821002198

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-NBAM1608A-1
In Commercial Distribution

  • 05712821002198 ()


  • Dental prosthesis/implant abutment screw

Elos Accurate® Hexalobular Prosthetic Screw - 05712821002181

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-NBAM1407A-1
In Commercial Distribution

  • 05712821002181 ()


  • Dental prosthesis/implant abutment screw

Elos Accurate® Hexalobular Prosthetic Screw - 05712821002167

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-ATOM2010A-1
In Commercial Distribution

  • 05712821002167 ()


  • Dental prosthesis/implant abutment screw

Elos Accurate® Hexalobular Prosthetic Screw - 05712821002150

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-ATOM1608A-1
In Commercial Distribution

  • 05712821002150 ()


  • Dental prosthesis/implant abutment screw

Elos Accurate® Hexalobular Prosthetic Screw - 05712821002143

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-ATOM1408A-1
In Commercial Distribution

  • 05712821002143 ()


  • Dental prosthesis/implant abutment screw

Elos Accurate® Hexalobular Prosthetic Screw - 05712821002136

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-ATEM2008A-1
In Commercial Distribution

  • 05712821002136 ()


  • Dental prosthesis/implant abutment screw

Elos Accurate® Hexalobular Prosthetic Screw - 05712821002129

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-ATEM1808A-1
In Commercial Distribution

  • 05712821002129 ()


  • Dental prosthesis/implant abutment screw

Elos Accurate® Hexalobular Prosthetic Screw - 05712821002112

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-ATEM1608A-1
In Commercial Distribution

  • 05712821002112 ()


  • Dental prosthesis/implant abutment screw

Elos Accurate® Hexalobular Prosthetic Screw - 05712821002105

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-ATEM1408A-1
In Commercial Distribution

  • 05712821002105 ()


  • Dental prosthesis/implant abutment screw

Torque Wrench EV Restorative Driver Handle 4 ×4 Low - 05712821000057

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
25730
In Commercial Distribution

  • 05712821000057 ()
  • 05712821009357 ()


  • Surgical torque wrench adaptor

Torque Wrench EV Restorative Driver Handle Low - 05712821000040

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
25777
In Commercial Distribution

  • 05712821000040 ()
  • 05712821009418 ()


  • Surgical torque wrench adaptor

Torque Wrench EV Restorative Driver Handle - 05712821000033

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
25776
In Commercial Distribution

  • 05712821000033 ()
  • 05712821009395 ()


  • Surgical torque wrench adaptor

Torque Wrench EV Surgical Driver Handle - 05712821000026

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
25775
In Commercial Distribution

  • 05712821000026 ()
  • 05712821009449 ()


  • Surgical torque wrench adaptor

SubQ It! Bioabsorbable Skin Closure System - 00867469000237

SubQ It! Bioabsorbable Driver SU-10 is a single-patient use, skin closure device, preloaded with 10 bioabsorbable dermal fasteners, packaged sterile in a protective foil pouch.
OPUS KSD, INC.
SU-10
In Commercial Distribution

  • 10867469000234 ()
  • 00867469000237 ()
412010

  • Skin stapler/staple, bioabsorbable

AccuPlan System - 00864582000298

ORTHOGNATHIC, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES AND TITANIUM HYBRID GUIDES, SINGLE JAW
Medcad
MC-KTP010-H
In Commercial Distribution

  • 00864582000298 ()
MC-KTP010-H

  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Craniofacial fixation plate, non-bioabsorbable, non-customized

Atlas Pro Driver Collet Attachment Hex - 00862377000171

No Description
PRO-DEX, INC.
APD-CA-001-1
In Commercial Distribution

  • 00862377000171 ()


  • Screwing power tool attachment

KLS MARTIN SURGICAL DRIVER - 00862377000133

No Description
PRO-DEX, INC.
KLS-SD-1000
In Commercial Distribution

  • 00862377000133 ()


  • Bone/joint surgical power tool motorized handpiece/set, electric, reusable

MatrixPRO driver Handpiece - 00862377000102

No Description
PRO-DEX, INC.
05.000.020
In Commercial Distribution

  • 00862377000102 ()


  • Bone/joint surgical power tool motorized handpiece/set, electric, reusable

Screwdriver HexaDrive - 05712149027408

Screwdriver HexaDrive. Consists of blade (DM DI 05712149027415) and handle (DM DI 057121490274225).
Oticon Medical AB
265497
In Commercial Distribution

  • 05712149027408 ()
  • 05712149027415 ()
265497

  • Surgical screwdriver, reusable

Ponto - 05712149009909

Insertion indicator
Oticon Medical AB
M52366
Not in Commercial Distribution

  • 05712149009909 ()
M52366

  • Surgical screwdriver, reusable

Ponto - 05712149005895

Abutment inserter, machine
Oticon Medical AB
M51695
In Commercial Distribution

  • 05712149005895 ()
M51695

  • Surgical screwdriver, reusable

Ponto - 05712149001026

Screwdriver hexagon
Oticon Medical AB
M50534
In Commercial Distribution

  • 05712149001026 ()
M50534

  • Surgical screwdriver, reusable

Ponto - 05712149000654

Handle with screwdriver. Consists of handle (DM DI 05712149024568) and screwdriver machine bit (DM DI 05712149000562).
Oticon Medical AB
M50437
In Commercial Distribution

  • 05712149000654 ()
  • 05712149024568 ()
M50437

  • Surgical screwdriver, reusable

Ponto - 05712149000586

Square fit connection, machine
Oticon Medical AB
M50386
In Commercial Distribution

  • 05712149000586 ()
M50386

  • Surgical screwdriver, reusable

Ponto - 05712149000562

Screwdriver, machine, 35mm
Oticon Medical AB
M50384
In Commercial Distribution

  • 05712149000562 ()
M50384

  • Surgical screwdriver, reusable

COMPREHENSIVE SRS HEX DRIVER - 00880304541917

No Description
Biomet Orthopedics, LLC
405234
In Commercial Distribution

  • 00880304541917 ()

  • 3.5MM
405234

  • Orthopaedic instrument surgical connector

DRIVER HANDLE - 00880304537927

No Description
Biomet Orthopedics, LLC
41018
In Commercial Distribution

  • 00880304537927 ()
41018

  • Surgical instrument handle, non-torque-limiting

AFFIXUS®LAG SCREW DRIVER CAPTURED - 00880304536012

No Description
Biomet Orthopedics, LLC
211201322
In Commercial Distribution

  • 00880304536012 ()
211201322

  • Surgical screwdriver, reusable

SQUARE DRIVER - 00880304533516

No Description
Biomet Orthopedics, LLC
231200101
In Commercial Distribution

  • 00880304533516 ()

  • 1.7MM
231200101

  • Surgical screwdriver, reusable

Explorer TO - 10889981207182

Lordosis Expansion Driver
Seaspine Orthopedics Corporation
ET2-001101
In Commercial Distribution

  • 10889981207182 ()
ET2-001101

  • Orthopaedic implant driver
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