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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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Light A2 SmarTemp® 50ml. Cartridge
PARKELL, INC.
S340
Not in Commercial Distribution

  • M595S3400 ()
S340

  • Temporary dental crown/bridge resin
Ultralight A1 SmarTemp® Split 50ml. Cartridge
PARKELL, INC.
S337
Not in Commercial Distribution

  • M595S3370 ()
S337

  • Temporary dental crown/bridge resin
Dual Cure A2 (Light Shade) SmarTemp® 50ml. Cartridge
PARKELL, INC.
S338
Not in Commercial Distribution

  • M595S3380 ()
S338

  • Temporary dental crown/bridge resin
Bifix Temp is a dual-curing, composite-based temporary luting material.
VOCO GmbH
1056
In Commercial Distribution

  • E22110561 ()
1056

  • Dental composite resin
Bifix Temp is a dual-curing, composite-based temporary luting material.
VOCO GmbH
1055
In Commercial Distribution

  • E22110551 ()
1055

  • Dental composite resin
The clamp holder is used to grip the implant.
NEWDEAL
239500ND
Not in Commercial Distribution

  • M248239500ND1 ()
  • 10381780051923 ()


  • Surgical implant handling forceps
The Viper cortical titanium screw, which is placed proximally.
Ascension Orthopedics, Inc.
28135018
Not in Commercial Distribution

  • M248281350181 ()
  • 10381780065180 ()

  • 3.5 mm dia x 21.2 mm L; 18 mm thread
28135018

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
The Viper cortical titanium screw, which is placed proximally.
Ascension Orthopedics, Inc.
28135016
Not in Commercial Distribution

  • M248281350161 ()
  • 10381780065173 ()

  • 3.5 mm dia x 19.2 mm L; 16 mm thread
28135016

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
The Viper cortical titanium screw, which is placed proximally.
Ascension Orthopedics, Inc.
28135014
Not in Commercial Distribution

  • M248281350141 ()
  • 10381780065166 ()

  • 3.5 mm dia x 17.2 mm L; 14 mm thread
28135014

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
The Viper cortical titanium screw, which is placed proximally.
Ascension Orthopedics, Inc.
28135012
Not in Commercial Distribution

  • M248281350121 ()
  • 10381780065159 ()

  • 3.5 mm dia x 15.2 mm L; 12 mm thread
28135012

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
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