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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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"PRTI - is a self-tapping titanium dental implant, pronounced conical shape, with variable thread, with internal Hex2.43 connection. Implants are made of medical titanium alloy Ti6Al4V ASTM-136. Implants are available in diameter 3.3; 3.75; 4.2; 5.0; 6.0 mm in diameter and length 5; 6; 7; 8; 10; 11.5; 13; 16mm. The outer surface of the implant undergoes double treatment (sandblasting and acid treatment). The texture of the outer surface of the implant has micropores of 1-4 microns in size and macropores of 30-40 microns in size. The external thread of the implant has a double spiral shape. The internal connection of the implant - a internal hexagon 2.43 mmd and internal thread 1-72 UNF for all diameters. Implant complete with disposable carrier-441113 (441113S for 5-7mm short implants) and titanium cover screw-720638 (720638S for 5-7mm short implants). Used in all types of jaws. Recommended for bones of type D1, D2, D3. Implant areas - all parts of the upper and lower jaw. Indications - two-stage implantation."
DMI INNOVATIVE MEDICAL TECHNOLOGY LTD
A
Not in Commercial Distribution

  • 07290112765871 ()

  • Length: 10 Millimeter
  • Outer Diameter: 3.3 Millimeter
  • H2.43mm
111033

  • Screw endosteal dental implant, two-piece
"PRTI - is a self-tapping titanium dental implant, pronounced conical shape, with variable thread, with internal Hex2.43 connection. Implants are made of medical titanium alloy Ti6Al4V ASTM-136. Implants are available in diameter 3.3; 3.75; 4.2; 5.0; 6.0 mm in diameter and length 5; 6; 7; 8; 10; 11.5; 13; 16mm. The outer surface of the implant undergoes double treatment (sandblasting and acid treatment). The texture of the outer surface of the implant has micropores of 1-4 microns in size and macropores of 30-40 microns in size. The external thread of the implant has a double spiral shape. The internal connection of the implant - a internal hexagon 2.43 mmd and internal thread 1-72 UNF for all diameters. Implant complete with disposable carrier-441113 (441113S for 5-7mm short implants) and titanium cover screw-720638 (720638S for 5-7mm short implants). Used in all types of jaws. Recommended for bones of type D1, D2, D3. Implant areas - all parts of the upper and lower jaw. Indications - two-stage implantation."
DMI INNOVATIVE MEDICAL TECHNOLOGY LTD
A
Not in Commercial Distribution

  • 07290112760081 ()

  • Length: 11.5 Millimeter
  • Outer Diameter: 3.75 Millimeter
  • Device Size Tex2.43
111137

  • Screw endosteal dental implant, two-piece
"PRTI - is a self-tapping titanium dental implant, pronounced conical shape, with variable thread, with internal Hex2.43 connection. Implants are made of medical titanium alloy Ti6Al4V ASTM-136. Implants are available in diameter 3.3; 3.75; 4.2; 5.0; 6.0 mm in diameter and length 5; 6; 7; 8; 10; 11.5; 13; 16mm. The outer surface of the implant undergoes double treatment (sandblasting and acid treatment). The texture of the outer surface of the implant has micropores of 1-4 microns in size and macropores of 30-40 microns in size. The external thread of the implant has a double spiral shape. The internal connection of the implant - a internal hexagon 2.43 mmd and internal thread 1-72 UNF for all diameters. Implant complete with disposable carrier-441113 (441113S for 5-7mm short implants) and titanium cover screw-720638 (720638S for 5-7mm short implants). Used in all types of jaws. Recommended for bones of type D1, D2, D3. Implant areas - all parts of the upper and lower jaw. Indications - two-stage implantation."
DMI INNOVATIVE MEDICAL TECHNOLOGY LTD
A
Not in Commercial Distribution

  • 07290112760067 ()

  • Length: 8 Millimeter
  • Outer Diameter: 5 Millimeter
  • Internal hex 2.43 mmd
111050

  • Screw endosteal dental implant, two-piece
"PRTI - is a self-tapping titanium dental implant, pronounced conical shape, with variable thread, with internal Hex2.43 connection. Implants are made of medical titanium alloy Ti6Al4V ASTM-136. Implants are available in diameter 3.3; 3.75; 4.2; 5.0; 6.0 mm in diameter and length 5; 6; 7; 8; 10; 11.5; 13; 16mm. The outer surface of the implant undergoes double treatment (sandblasting and acid treatment). The texture of the outer surface of the implant has micropores of 1-4 microns in size and macropores of 30-40 microns in size. The external thread of the implant has a double spiral shape. The internal connection of the implant - a internal hexagon 2.43 mmd and internal thread 1-72 UNF for all diameters. Implant complete with disposable carrier-441113 (441113S for 5-7mm short implants) and titanium cover screw-720638 (720638S for 5-7mm short implants). Used in all types of jaws. Recommended for bones of type D1, D2, D3. Implant areas - all parts of the upper and lower jaw. Indications - two-stage implantation."
DMI INNOVATIVE MEDICAL TECHNOLOGY LTD
A
Not in Commercial Distribution

  • 07290112760043 ()

  • Outer Diameter: 3.75 Millimeter
  • Length: 10 Millimeter
  • H2.43
111037

  • Screw endosteal dental implant, two-piece
"PRTI - is a self-tapping titanium dental implant, pronounced conical shape, with variable thread, with internal Hex2.43 connection. Implants are made of medical titanium alloy Ti6Al4V ASTM-136. Implants are available in diameter 3.3; 3.75; 4.2; 5.0; 6.0 mm in diameter and length 5; 6; 7; 8; 10; 11.5; 13; 16mm. The outer surface of the implant undergoes double treatment (sandblasting and acid treatment). The texture of the outer surface of the implant has micropores of 1-4 microns in size and macropores of 30-40 microns in size. The external thread of the implant has a double spiral shape. The internal connection of the implant - a internal hexagon 2.43 mmd and internal thread 1-72 UNF for all diameters. Implant complete with disposable carrier-441113 (441113S for 5-7mm short implants) and titanium cover screw-720638 (720638S for 5-7mm short implants). Used in all types of jaws. Recommended for bones of type D1, D2, D3. Implant areas - all parts of the upper and lower jaw. Indications - two-stage implantation."
DMI INNOVATIVE MEDICAL TECHNOLOGY LTD
A
Not in Commercial Distribution

  • 07290112760036 ()

  • Length: 8 Millimeter
  • Outer Diameter: 6 Millimeter
  • H2.43mm
110860

  • Screw endosteal dental implant, two-piece
"PRTI - is a self-tapping titanium dental implant, pronounced conical shape, with variable thread, with internal Hex2.43 connection. Implants are made of medical titanium alloy Ti6Al4V ASTM-136. Implants are available in diameter 3.3; 3.75; 4.2; 5.0; 6.0 mm in diameter and length 5; 6; 7; 8; 10; 11.5; 13; 16mm. The outer surface of the implant undergoes double treatment (sandblasting and acid treatment). The texture of the outer surface of the implant has micropores of 1-4 microns in size and macropores of 30-40 microns in size. The external thread of the implant has a double spiral shape. The internal connection of the implant - a internal hexagon 2.43 mmd and internal thread 1-72 UNF for all diameters. Implant complete with disposable carrier-441113 (441113S for 5-7mm short implants) and titanium cover screw-720638 (720638S for 5-7mm short implants). Used in all types of jaws. Recommended for bones of type D1, D2, D3. Implant areas - all parts of the upper and lower jaw. Indications - two-stage implantation."
DMI INNOVATIVE MEDICAL TECHNOLOGY LTD
A
Not in Commercial Distribution

  • 07290112760029 ()

  • Length: 8 Millimeter
  • Outer Diameter: 5 Millimeter
  • Hex 2.43 mmd
110850

  • Screw endosteal dental implant, two-piece
"PRTI - is a self-tapping titanium dental implant, pronounced conical shape, with variable thread, with internal Hex2.43 connection. Implants are made of medical titanium alloy Ti6Al4V ASTM-136. Implants are available in diameter 3.3; 3.75; 4.2; 5.0; 6.0 mm in diameter and length 5; 6; 7; 8; 10; 11.5; 13; 16mm. The outer surface of the implant undergoes double treatment (sandblasting and acid treatment). The texture of the outer surface of the implant has micropores of 1-4 microns in size and macropores of 30-40 microns in size. The external thread of the implant has a double spiral shape. The internal connection of the implant - a internal hexagon 2.43 mmd and internal thread 1-72 UNF for all diameters. Implant complete with disposable carrier-441113 (441113S for 5-7mm short implants) and titanium cover screw-720638 (720638S for 5-7mm short implants). Used in all types of jaws. Recommended for bones of type D1, D2, D3. Implant areas - all parts of the upper and lower jaw. Indications - two-stage implantation."
DMI INNOVATIVE MEDICAL TECHNOLOGY LTD
A
Not in Commercial Distribution

  • 07290112760012 ()

  • Length: 8 Millimeter
  • Outer Diameter: 4.2 Millimeter
  • Internal Hex 2.43 mmd
110842

  • Screw endosteal dental implant, two-piece
PRTI - is a self-tapping titanium dental implant, pronounced conical shape, with variable thread, with internal Hex2.43 connection. Implants are made of medical titanium alloy Ti6Al4V ASTM-136. Implants are available in diameter 3.3; 3.75; 4.2; 5.0; 6.0 mm in diameter and length 5; 6; 7; 8; 10; 11.5; 13; 16mm. The outer surface of the implant undergoes double treatment (sandblasting and acid treatment). The texture of the outer surface of the implant has micropores of 1-4 microns in size and macropores of 30-40 microns in size. The external thread of the implant has a double spiral shape. The internal connection of the implant - a internal hexagon 2.43 mmd and internal thread 1-72 UNF for all diameters. Implant complete with disposable carrier-441113 (441113S for 5-7mm short implants) and titanium cover screw-720638 (720638S for 5-7mm short implants). Used in all types of jaws. Recommended for bones of type D1, D2, D3. Implant areas - all parts of the upper and lower jaw. Indications - two-stage implantation.
DMI INNOVATIVE MEDICAL TECHNOLOGY LTD
A
Not in Commercial Distribution

  • 07290112760005 ()

  • Outer Diameter: 3.75 Millimeter
  • Length: 8 Millimeter
110837

  • Screw endosteal dental implant, two-piece
The AbClose - Port Site Closure Device is a sterile, single-use device including 2 major components, Suture Guide and Suture Passer. The device is used with a commercially cleared suture, and is used as a manual instrument to pass needles with suture through soft tissues for suturing. The device is designed with a suture retrieval system for unassisted fascial closures, facilitating standard suture closure techniques. The Suture Guide is structured by a Handle and a Suture Catcher. The pyramid-shape Suture Catcher is controlled by a Push Button to fold the Suture Catcher into cylinder shape for insertion into the trocar wound. Once the Suture Guide is in position, Suture Catcher is expanded back to a pyramid shape to stabilize the device on the trocar wound site. The Suture Passer is a handheld suture grasping device designed to pass sutures through soft tissue. It features a Handle and a stainless steel Needle assembled with a Suture Shaft that grasps a suture. The Suture Passer is designed to work with the Suture Guide to penetrate through soft tissues and deploy suture ends into the Suture Catcher. Withdraw Suture Guide by fold the Suture Catcher into cylinder shape, the two suture ends are securely captured and are ready for user to type knots to close the trocar wound site. The AbClose - Port Site Closure Device is intended to be used by clinicians through prescription use only.
MEDEON BIODESIGN, INC.
M12
In Commercial Distribution

  • 04719872920014 ()
  • 04719872920021 ()
  • 04719872920076 ()
M12

  • Gastrointestinal endoscopic clip, long-term, non-bioabsorbable
The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant. The customized shape of the abutment shall be manufactured by either an Elos Medtech approved milling facility or at point of use. The Pre-Milled abutment is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.
Elos Medtech Pinol A/S
CPMB-ATE30-1
In Commercial Distribution

  • 05712821011527 ()
CPMB-ATE30-1

  • Dental implant suprastructure, permanent, preformed
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