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 Class Implantable

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No Description
PRIMOTEC LLC
PS100US
In Commercial Distribution

  • D831PS100US1 ()
  • D831PS100US0 ()


  • Dental occlusal splint, custom-made
No Description
ICP, INC.
51-9597150
In Commercial Distribution

  • D7715195971500 ()
  • D7715195971501 ()


  • Dental appliance fabrication material, thermoplastic
No Description
ICP, INC.
51-9597090
In Commercial Distribution

  • D7715195970900 ()
  • D7715195970901 ()


  • Dental appliance fabrication material, thermoplastic
No Description
ICP, INC.
51-9596980
In Commercial Distribution

  • D7715195969800 ()
  • D7715195969801 ()


  • Dental appliance fabrication material, thermoplastic
DELTASPLINT, 12 Rods
DeltaMed GmbH
1370010
In Commercial Distribution

  • EDEL13700100 ()
  • EDEL13700101 ()
1370010

  • Dental occlusal splint, custom-made
THERMEO Blank, diameter 98.5 mm, height 25 mm
pro3dure medical GmbH
clear transparent, height 25 mm
In Commercial Distribution

  • EPRCD1022006 ()
D1022006

  • Custom-made mouthguard
THERMEO Blank, diameter 98.5 mm, height 20 mm
pro3dure medical GmbH
clear transparent, height 20 mm
In Commercial Distribution

  • EPRCD1022003 ()


  • Custom-made mouthguard
THERMEO Blank, diameter 98.5 mm, height 16 mm
pro3dure medical GmbH
clear transparent, height 16 mm
In Commercial Distribution

  • EPRCD1022002 ()


  • Custom-made mouthguard
THERMEO Blank, diameter 98.5 mm, height 20 mm
pro3dure medical GmbH
color A3, height 20 mm
In Commercial Distribution

  • EPRCD1010127 ()


  • Custom-made mouthguard
THERMEO Blank, diameter 98.5 mm, height 20 mm
pro3dure medical GmbH
color A2, height 20 mm
In Commercial Distribution

  • EPRCD1010126 ()


  • Custom-made mouthguard
THERMEO Blank, diameter 98.5 mm, height 20 mm
pro3dure medical GmbH
color A1, height 20 mm
In Commercial Distribution

  • EPRCD1010125 ()


  • Custom-made mouthguard
THERMEO Liquid
pro3dure medical GmbH
600 ml Liquid - clear transparent
In Commercial Distribution

  • EPRCD1010124 ()


  • Custom-made mouthguard
THERMEO Liquid
pro3dure medical GmbH
255 ml Liquid - clear transparent
In Commercial Distribution

  • EPRCD1010123 ()


  • Custom-made mouthguard
THERMEO Liquid
pro3dure medical GmbH
130 ml Liquid - clear transparent
In Commercial Distribution

  • EPRCD1010122 ()


  • Custom-made mouthguard
THERMEO Powder
pro3dure medical GmbH
800 g Powder - clear transparent
In Commercial Distribution

  • EPRCD1010121 ()


  • Custom-made mouthguard
THERMEO Powder
pro3dure medical GmbH
340 g Powder - clear transparent
In Commercial Distribution

  • EPRCD1010120 ()


  • Custom-made mouthguard
THERMEO Powder
pro3dure medical GmbH
180 g Powder - clear transparent
In Commercial Distribution

  • EPRCD1010119 ()


  • Custom-made mouthguard
No Description
PRIMOTEC LLC
PSKIT1
In Commercial Distribution

  • D831PSKIT1 ()


  • Dental occlusal splint, custom-made
No Description
PRIMOTEC LLC
PS204US
In Commercial Distribution

  • D831PS204US0 ()


  • Dental occlusal splint, custom-made
No Description
PRIMOTEC LLC
PS202US
In Commercial Distribution

  • D831PS202US0 ()


  • Dental occlusal splint, custom-made
The POD
SELANE PRODUCTS, INC.
62065
In Commercial Distribution

  • D854620651 ()


  • Custom-made mouthguard
DENTURE MATERIAL - SUPER ECONO KIT - PACKAGE 960 GRAMS POWDER/3 EACH 240 GRAMS LIQUID
ASTRON DENTAL CORPORATION
PCSRSEK1
In Commercial Distribution

  • D810PCSRSEK11 ()
PCSRSEK1

  • Custom-made mouthguard
DENTURE MATERIAL - PACKAGE 160 GRAMS POWDER/120 GRAMS LIQUID
ASTRON DENTAL CORPORATION
PCSRLK1
In Commercial Distribution

  • D810PCSRLK11 ()
PCSRLK1

  • Custom-made mouthguard
DENTURE MATERIAL - PACKAGE 320 GRAMS POWDER / 240 GRAMS LIQUID
ASTRON DENTAL CORPORATION
PCSREK1
In Commercial Distribution

  • D810PCSREK11 ()
PCSREK1

  • Custom-made mouthguard
DENTURE MATERIAL - SUPER ECONO KIT - PACKAGE 960 GRAMS POWDER/ 3 EACH 240 GRAMS LIQUID
ASTRON DENTAL CORPORATION
PCSFSEK1
In Commercial Distribution

  • D810PCSFSEK11 ()
PCSFSEK1

  • Custom-made mouthguard
DENTURE MATERIAL - PACKAGE 160 GRAMS POWDER/120 GRAMS LIQUID
ASTRON DENTAL CORPORATION
PCSFLK1
In Commercial Distribution

  • D810PCSFLK11 ()
PCSFLK1

  • Custom-made mouthguard
DENTURE MATERIAL - PACKAGE 320 GRAMS POWDER / 240 GRAMS LIQUID
ASTRON DENTAL CORPORATION
PCSFEK1
In Commercial Distribution

  • D810PCSFEK11 ()
PCSFEK1

  • Custom-made mouthguard
Package of 1 disc 98mmX20mm with shoulder
ASTRON DENTAL CORPORATION
PCSD98
In Commercial Distribution

  • D810PCSD985111 ()
PCSD98

  • Mouthguard, single-use
Clearsplint Disc 98mm x 25mm Shoulder Magenta BES 1 Unit
ASTRON DENTAL CORPORATION
PCSD2598BESM1
In Commercial Distribution

  • D810PCSD2598BESM111 ()
PCSD2598BESM1

  • Mouthguard, single-use
Clearsplint Disc 98mm x 25mm Shoulder Blue BES 1 Unit
ASTRON DENTAL CORPORATION
PCSD2598BESB1
In Commercial Distribution

  • D810PCSD2598BESB111 ()
PCSD2598BESB1

  • Mouthguard, single-use
Clearsplint Disc 98mm x 25mm Shoulder Clear BES 1 Unit
ASTRON DENTAL CORPORATION
PCSD2598BES1
In Commercial Distribution

  • D810PCSD2598BES111 ()
PCSD2598BES1

  • Mouthguard, single-use
Clearsplint Disc 95mm x 25mm Clover Edge Magenta BES 1 Unit
ASTRON DENTAL CORPORATION
PCSD2595ZBESM1
In Commercial Distribution

  • D810PCSD2595ZBESM111 ()
PCSD2595ZBESM1

  • Mouthguard, single-use
Clearsplint Disc 95mm x 25mm Clover Edge Blue BES 1 Unit
ASTRON DENTAL CORPORATION
PCSD2595ZBESB1
In Commercial Distribution

  • D810PCSD2595ZBESB111 ()
PCSD2595ZBESB1

  • Mouthguard, single-use
Clearsplint Disc 95mm x 25 mm Clover Edge Clear BES 1 Unit
ASTRON DENTAL CORPORATION
PCSD2595ZBES1
In Commercial Distribution

  • D810PCSD2595ZBES111 ()
PCSD2595ZBES1

  • Mouthguard, single-use
Package of 1 disc 98mmX20mm with no shoulder
ASTRON DENTAL CORPORATION
PCSD98N
In Commercial Distribution

  • D810PCSD2098NS111 ()
PCSD98N

  • Mouthguard, single-use
Clearsplint Disc 98mm x 20mm Shoulder Magenta BES 1 Unit
ASTRON DENTAL CORPORATION
PCSD2098BESM1
In Commercial Distribution

  • D810PCSD2098BESM111 ()
PCSD2098BESM1

  • Mouthguard, single-use
Clearsplint Disc 98mm x 20mm Shoulder Blue BES 1 Unit
ASTRON DENTAL CORPORATION
PCSD2098BESB1
In Commercial Distribution

  • D810PCSD2098BESB111 ()
PCSD2098BESB1

  • Mouthguard, single-use
Clearsplint Disc 95mm x 20mm Clover Edge Magenta BES 1 Unit
ASTRON DENTAL CORPORATION
PCSD2095ZBESM1
In Commercial Distribution

  • D810PCSD2095ZBESM111 ()
PCSD2095ZBESM1

  • Mouthguard, single-use
Clearsplint Disc 95mm x 20mm Clover Edge Blue BES 1 Unit
ASTRON DENTAL CORPORATION
PCSD2095ZBESB1
In Commercial Distribution

  • D810PCSD2095ZBESB111 ()
PCSD2095ZBESB1

  • Mouthguard, single-use
Package of 1 disc 95mmX20mm Zirkonzahn/Clover Leaf Edge
ASTRON DENTAL CORPORATION
PCSD95
In Commercial Distribution

  • D810PCSD2095Z111 ()
PCSD95

  • Mouthguard, single-use
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