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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Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 12 months at 5°C.
Temptime Corporation
F12
In Commercial Distribution

  • 00852282007037 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 9 months at 5°C.
Temptime Corporation
F9
In Commercial Distribution

  • 00852282007020 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 182 days at 5°C.
Temptime Corporation
F6
In Commercial Distribution

  • 00852282007013 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 91 days at 5°C.
Temptime Corporation
F3
In Commercial Distribution

  • 00852282007006 ()


  • Medical product temperature point indicator, thermochemical
Resin root canal sealer for dental endodontic treatment
MICRO MEGA
none
In Commercial Distribution

  • J015206000360 ()
20600106

  • Endodontic filling/sealing material
Hydrophillic Impression Material
DEN-MAT HOLDINGS, LLC
1-016399
In Commercial Distribution

  • 00359883006631 ()

  • Total Volume: 50 Milliliter
1-016399

  • Silicone dental impression material
Gingival Retraction Solution
DEN-MAT HOLDINGS, LLC
641904
In Commercial Distribution

  • 00359883005665 ()

  • Total Volume: 12 Milliliter
641904

  • Gingival retraction solution
Hydrophillic Impression Material
DEN-MAT HOLDINGS, LLC
1-016409
In Commercial Distribution

  • 00359883003388 ()

  • Total Volume: 50 Milliliter
1-016409

  • Silicone dental impression material
Hydrophillic Impression Material
DEN-MAT HOLDINGS, LLC
1-016408
In Commercial Distribution

  • 00359883003371 ()

  • Total Volume: 50 Milliliter
1-016408

  • Silicone dental impression material
Hydrophillic Impression Material
DEN-MAT HOLDINGS, LLC
1-016407
In Commercial Distribution

  • 00359883003364 ()

  • Total Volume: 50 Milliliter
1-016407

  • Silicone dental impression material
Hydrophillic Impression Material
DEN-MAT HOLDINGS, LLC
1-016406
In Commercial Distribution

  • 00359883003357 ()

  • Total Volume: 50 Milliliter
1-016406

  • Silicone dental impression material
Hydrophillic Impression Material
DEN-MAT HOLDINGS, LLC
1-016405
In Commercial Distribution

  • 00359883003340 ()

  • Total Volume: 600 Milliliter
1-016405

  • Silicone dental impression material
Hydrophillic Impression Material
DEN-MAT HOLDINGS, LLC
1-016404
In Commercial Distribution

  • 00359883003326 ()
  • 00359883003333 ()

  • Total Volume: 300 Milliliter
1-016404

  • Silicone dental impression material
Hydrophillic Impression Material
DEN-MAT HOLDINGS, LLC
1-016403
In Commercial Distribution

  • 00359883003302 ()
  • 00359883003319 ()

  • Total Volume: 300 Milliliter
1-016403

  • Silicone dental impression material
Hydrophillic Impression Material
DEN-MAT HOLDINGS, LLC
1-016402
In Commercial Distribution

  • 00359883003289 ()
  • 00359883003296 ()

  • Total Volume: 300 Milliliter
1-016402

  • Silicone dental impression material
Hydrophillic Impression Material
DEN-MAT HOLDINGS, LLC
1-016401
In Commercial Distribution

  • 00359883003265 ()
  • 00359883003272 ()

  • Total Volume: 300 Milliliter
1-016401

  • Silicone dental impression material
Hydrophillic Impression Material
DEN-MAT HOLDINGS, LLC
1-016400
In Commercial Distribution

  • 00359883003241 ()
  • 00359883003258 ()

  • Total Volume: 300 Milliliter
1-016400

  • Silicone dental impression material
Hydrophillic Impression Material
DEN-MAT HOLDINGS, LLC
1-016397
In Commercial Distribution

  • 00359883003227 ()

  • Total Volume: 50 Milliliter
1-016397

  • Silicone dental impression material
VPS Impression Material
DEN-MAT HOLDINGS, LLC
023406
In Commercial Distribution

  • 00359883002107 ()
  • 00359883002114 ()

  • Total Volume: 120 Milliliter
023406

  • Silicone dental impression material
VPS Impression Material
DEN-MAT HOLDINGS, LLC
023401
In Commercial Distribution

  • 00359883002046 ()
  • 00359883002053 ()

  • Total Volume: 120 Milliliter
023401

  • Silicone dental impression material
VPS Impression Material
DEN-MAT HOLDINGS, LLC
022406
In Commercial Distribution

  • 00359883001988 ()
  • 00359883001995 ()

  • Total Volume: 120 Milliliter
022406

  • Silicone dental impression material
VPS Impression Material
DEN-MAT HOLDINGS, LLC
022401
In Commercial Distribution

  • 00359883001926 ()
  • 00359883001933 ()

  • Total Volume: 120 Milliliter
022401

  • Silicone dental impression material
VPS Impression Material
DEN-MAT HOLDINGS, LLC
013406
In Commercial Distribution

  • 00359883001599 ()

  • Total Volume: 120 Milliliter
013406

  • Silicone dental impression material
VPS Impression Material
DEN-MAT HOLDINGS, LLC
013401
In Commercial Distribution

  • 00359883001575 ()

  • Total Volume: 120 Milliliter
013401

  • Silicone dental impression material
VPS Impression Material
DEN-MAT HOLDINGS, LLC
012406
In Commercial Distribution

  • 00359883001513 ()

  • Total Volume: 120 Milliliter
012406

  • Silicone dental impression material
VPS Impression Material
DEN-MAT HOLDINGS, LLC
012401
In Commercial Distribution

  • 00359883001490 ()

  • Total Volume: 120 Milliliter
012401

  • Silicone dental impression material
Seal & Protect™ Protective Sealant for Exposed Dentin. Contains: 2 Holders, 50 Brush Stixx
Dentsply Professional
658010
In Commercial Distribution

  • D0036580101 ()


  • Dental unfilled resin sealant/coating
DELTON® FS+ FLOWABLE Pit & Fissure Sealant with FLUORIDE Light Curing Opaque. Refill Kit. Also contains: Delton® Syringes, EZ Etch Syringe, EZ Tips, and Syringe Sleeves.
Dentsply Professional
310201
In Commercial Distribution

  • D0033102012 ()
  • D0033102011 ()

  • Weight: 1.9 Gram


  • Cable/lead/sensor/probe cover, non-sterile
  • Dental composite resin
DELTON® FS+ FLOWABLE Pit & Fissure Sealant with FLUORIDE Light Curing Opaque. Also contains: Delton® Syringes, EZ Etch Syringe, EZ Tips, and Syringe Sleeves.
Dentsply Professional
310101
In Commercial Distribution

  • D0033101012 ()
  • D0033101011 ()

  • Weight: 1.9 Gram


  • Cable/lead/sensor/probe cover, non-sterile
  • Dental composite resin
DELTON® PLUS Pit & Fissure Sealant with Fluoride Direct Delivery System Light Curing, Opaque. Contents: 50 DDS Cartridges of 4 ml.
Dentsply Professional
2896
In Commercial Distribution

  • D00328962 ()
  • D00328961 ()
  • D00328960 ()


  • Dental composite resin
DELTON® PLUS Pit & Fissure Sealant with FLUORIDE Direct Delivery System Light Curing, Opaque. Contents: 1 DDS Autoclavable Applicator, 50 Cartridges of 4 ml Sealant, EZ Etch Syringe of 3ml, 25 Etch Brush Tips.
Dentsply Professional
2894
In Commercial Distribution

  • D00328942 ()
  • D00328941 ()


  • Dental composite resin
DELTON® Regular Kit Light Curing Pit & Fissure Sealant, Opaque. Contents: 2 sealant bottles of 2.mL, Etchant bottle of 7 mL, Applicator with Tubes, Disposable Mixing Trays.
Dentsply Professional
27975
In Commercial Distribution

  • D003279752 ()
  • D003279751 ()


  • Dental unfilled resin sealant/coating
DELTON® Regular Kit Light Curing Pit and Fissure Sealant, Clear. Contents: 2 sealant bottles of 2.mL, Etchant bottle of 7 mL, Applicator with Tubes, Disposable Mixing Trays.
Dentsply Professional
27965
In Commercial Distribution

  • D003279652 ()
  • D003279651 ()


  • Dental unfilled resin sealant/coating
DELTON® Pit & Fissure Sealant Direct Delivery System Light Curing Opaque. Contains: 50 Cartridges - 4 ml
Dentsply Professional
2696
In Commercial Distribution

  • D00326962 ()
  • D00326961 ()
  • D00326960 ()

  • Total Volume: 4 Milliliter


  • Dental unfilled resin sealant/coating
DELTON® Pit & Fissure Sealant Direct Delivery System Light Curing Clear. Contains: 50 Cartridges - 4 ml
Dentsply Professional
2695
In Commercial Distribution

  • D00326952 ()
  • D00326951 ()
  • D00326950 ()

  • Total Volume: 4 Milliliter


  • Dental unfilled resin sealant/coating
EZ Etch 34% Etchant Gel. Contains: 2 Syringes (3 mL each) and 25 Tips.
Dentsply Professional
2103
In Commercial Distribution

  • D00321032 ()
  • D00321031 ()

  • Total Volume: 3 Milliliter


  • Dental etching solution
Comspan Composite Luting Cement Opaque Catalyst
DENTSPLY INTERNATIONAL INC.
955251
In Commercial Distribution

  • D0029552511 ()

  • 1x jar Catalyst (5g)
  • Weight: 5 Gram
955251

  • Dental composite resin
Comspan Composite Luting Cement Opaque Base
DENTSPLY INTERNATIONAL INC.
955250
In Commercial Distribution

  • D0029552501 ()

  • 1x jar Base (5g)
  • Weight: 5 Gram
955250

  • Dental composite resin
Prime&Bond® XP Etch&Rinse Adhesive Unit Dose Package
DENTSPLY INTERNATIONAL INC.
693002
In Commercial Distribution

  • D0026930020 ()
  • D0026930021 ()
693002

  • Dentine bonding agent/set
Aquasil Ultra XLV (Extra Low Viscosity) 4-Pack Refill Cartridges (Orange)
DENTSPLY INTERNATIONAL INC.
678781
Not in Commercial Distribution

  • D0026787810 ()
  • D0026787811 ()
678781

  • Silicone dental impression material
Aquasil Ultra LV (Low Viscosity) 4-Pack Refill Cartridges (Teal)
DENTSPLY INTERNATIONAL INC.
678779
Not in Commercial Distribution

  • D0026787790 ()
  • D0026787791 ()
678779

  • Silicone dental impression material
Aquasil® Ultra XLV Regular Set Cartridge Refill (Asia Only)
DENTSPLY INTERNATIONAL INC.
678769KR
In Commercial Distribution

  • D002678769KR0 ()
  • D002678769KR1 ()

  • 4 Cartridges (50mL each)
678769KR

  • Silicone dental impression material
Aquasil Ultra+ XLV FS 2-Pack Cartridge Refill
DENTSPLY INTERNATIONAL INC.
678714
In Commercial Distribution

  • D0026787140 ()
  • D0026787141 ()
678714

  • Silicone dental impression material
Aquasil Ultra+ LV FS 2-Pack Cartridge Refill
DENTSPLY INTERNATIONAL INC.
678713
In Commercial Distribution

  • D0026787130 ()
  • D0026787131 ()
678713

  • Silicone dental impression material
Aquasil Ultra+ XLV RS 2-Pack Cartridge Refill
DENTSPLY INTERNATIONAL INC.
678707
In Commercial Distribution

  • D0026787070 ()
  • D0026787071 ()
678707

  • Silicone dental impression material
Aquasil Ultra+ LV RS 2-Pack Cartridge Refill
DENTSPLY INTERNATIONAL INC.
678706
In Commercial Distribution

  • D0026787060 ()
  • D0026787061 ()
678706

  • Silicone dental impression material
Aquasil Ultra+ Tray Material Bulk Cartridge Refill, Heavy Extended Set (Green)
DENTSPLY INTERNATIONAL INC.
678704
In Commercial Distribution

  • D0026787040 ()
  • D0026787041 ()
678704

  • Silicone dental impression material
Aquasil Ultra+ Tray Material Cartridge Refill, Heavy Extended Set (Green)
DENTSPLY INTERNATIONAL INC.
678703
In Commercial Distribution

  • D0026787030 ()
  • D0026787031 ()
678703

  • Silicone dental impression material
Aquasil Ultra+ XLV Extended Set (Orange)
DENTSPLY INTERNATIONAL INC.
678702
Not in Commercial Distribution

  • D0026787020 ()
  • D0026787021 ()
678702

  • Silicone dental impression material
Aquasil Ultra+ XLV Extended Set 4-Pack Cartridge Refill (Orange)
DENTSPLY INTERNATIONAL INC.
678701
In Commercial Distribution

  • D0026787010 ()
  • D0026787011 ()
678701

  • Silicone dental impression material
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