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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Aquasil® Ultra+ XLV Regular Set Large digit® 50 pack
DENTSPLY INTERNATIONAL INC.
678644
In Commercial Distribution

  • D0026786441 ()
  • D0026786440 ()

  • Total Volume: 2.4 Milliliter
  • 50 (2.4mL) Large Unit Doses, 50 Mix Tips, 50 Intraoral Tips
678644

  • Silicone dental impression material
Aquasil® Ultra+ XLV Regular Set Small digit® 50 pack
DENTSPLY INTERNATIONAL INC.
678643
In Commercial Distribution

  • D0026786431 ()
  • D0026786430 ()

  • Total Volume: 1.6 Milliliter
  • 50 (1.6mL) Small Unit Doses, 50 Mix Tips, 50 Intraoral Tips
678643

  • Silicone dental impression material
Aquasil® Ultra+ LV Fast Set Small digit® 50 pack
DENTSPLY INTERNATIONAL INC.
678642
In Commercial Distribution

  • D0026786421 ()
  • D0026786420 ()

  • 50 (1.6mL) Small Unit Doses, 50 Mix Tips, 50 Intraoral Tips
  • Total Volume: 1.6 Milliliter
678642

  • Silicone dental impression material
Aquasil® Ultra+ LV Regular Set Large digit® 50 pack
DENTSPLY INTERNATIONAL INC.
678641
In Commercial Distribution

  • D0026786411 ()
  • D0026786410 ()

  • 50 (2.4mL) Large Unit Doses, 50 Mix Tips, 50 Intraoral Tips
  • Total Volume: 2.4 Milliliter
678641

  • Silicone dental impression material
Aquasil® Ultra+ LV Regular Set Small digit® 50 pack
DENTSPLY INTERNATIONAL INC.
678640
In Commercial Distribution

  • D0026786401 ()
  • D0026786400 ()

  • 50 (1.6mL) Small Unit Doses, 50 Mix Tips, 50 Intraoral Tips
  • Total Volume: 1.6 Milliliter
678640

  • Silicone dental impression material
Whip Mix Nasopharyngeal Swab is a 3D printed device designed to collect test samples from patient.
WHIP-MIX CORPORATION
70203
Not in Commercial Distribution

  • D040702031 ()
70203

  • Oral/upper respiratory tract specimen collection swab
T-Saver Blue/Orange C&B Mix Tip, Bag of 25, 3.2 mm diameter, 57.6 mm length
BENCO DENTAL SUPPLY CO.
4898-908
In Commercial Distribution

  • 00366975025906 ()


  • Dental material mixing nozzle
Mixing tips 15 pcs. Mixing tips used for dispensing EZ PickUp material from auto mix cartridges.
STERNGOLD DENTAL LLC
220233
In Commercial Distribution

  • 00841549118210 ()


  • Dental material mixing nozzle
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Spanish.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-02 S
In Commercial Distribution

  • D801SP6502S1 ()
65-02

  • Dentine adhesive
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Non-Boxed.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-021 N
In Commercial Distribution

  • D801SP65021N1 ()
65-021

  • Dentine adhesive
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Boxed.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-021 B
In Commercial Distribution

  • D801SP65021B1 ()
65-021

  • Dentine adhesive
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Syringe. Italian..
SCIENTIFIC PHARMACEUTICALS, INC.
ID 65-024 I
In Commercial Distribution

  • D801ID65024I1 ()
65-024

  • Dentine adhesive
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix. Primer. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 65-021 I
In Commercial Distribution

  • D801ID65021I1 ()
65-021

  • Dentine adhesive
3M™ ESPE™ Ketac™ Nano Light-Curing Glass Ionomer Quick Mix Restorative Trial Kit, 3305TK
3M COMPANY
3305TK
In Commercial Distribution

  • 50605861012077 ()
  • 30605861012073 ()
3305TK

  • Glass ionomer dental cement
"The MGB Alert Platinum Master Mix is intended for use in the development of laboratory assays which target DNA analytes using real-time PCR. The MGB Alert Platinum Master Mix itself generates no diagnostic information or data."
Elitechgroup Mdx LLC
M800694
In Commercial Distribution

  • 03661540951824 ()
M800694

  • Nucleic acid amplification mastermix kit IVD
The MGB Alert Platinum Master Mix is intended for use in the development of laboratory assays which target DNA analytes using real-time PCR. The MGB Alert Platinum Master Mix itself generates no diagnostic information or data.
Elitechgroup Mdx LLC
M800693
In Commercial Distribution

  • 03661540951817 ()
M800693

  • Nucleic acid amplification mastermix kit IVD
The MGB Alert Platinum Master Mix is intended for use in the development of laboratory assays which target DNA analytes using real-time PCR. The MGB Alert Platinum Master Mix itself generates no diagnostic information or data.
Elitechgroup Mdx LLC
M800691
In Commercial Distribution

  • 03661540951800 ()
M800691

  • Nucleic acid amplification mastermix kit IVD
The MGB Alert Platinum Master Mix is intended for use in the development of laboratory assays which target DNA analytes using real-time PCR. The MGB Alert Platinum Master Mix itself generates no diagnostic information or data.
Elitechgroup Mdx LLC
M800599-am
In Commercial Distribution

  • 03661540951794 ()
M800599-am

  • Nucleic acid amplification mastermix kit IVD
The MGB Alert Platinum Master Mix is intended for use in the development of laboratory assays which target DNA analytes using real-time PCR. The MGB Alert Platinum Master Mix itself generates no diagnostic information or data.
Elitechgroup Mdx LLC
M800599
In Commercial Distribution

  • 03661540950278 ()
M800599

  • Nucleic acid amplification mastermix kit IVD
This kit is used for extrusion of teeth. This is a chemical cure self mix kit containing 3 Oval Attachments with Chain and 2 Pad Attachments with Chain, Excel Regular Self Mix syringe and Assure Bonding Resin.
RELIANCE ORTHODONTIC PRODUCTS INC
CCCCK
Not in Commercial Distribution

  • D798CCCK0 ()
CCCCK

  • Dentine bonding agent/set
  • Orthodontic aligner auxiliary attachment kit
  • Orthodontic bracket adhesive
Pantos R 2.0 | C SC119_ Gun Green Havana Mix/Melanin AR Vintage Grey - B4.5 : 46 * 25 148
TAVAT EYEWEAR SRL
SC119_46GGR SV
In Commercial Distribution

  • 08053879821018 ()


  • Tinted non-prescription spectacles
Mixing tips 50 pcs. Mixing tips used for dispensing Stern Vantage Impression Material from auto mix cartridges.
STERNGOLD DENTAL LLC
220162
In Commercial Distribution

  • 00841549115936 ()


  • Dental material mixing nozzle
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix. Paste / Liquid. Carpule.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 67-02
In Commercial Distribution

  • D801SP67021 ()
67-02

  • Dentine adhesive
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Trial Syringe.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-12
In Commercial Distribution

  • D801SP65121 ()
65-12

  • Dentine adhesive
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix. Trial Size. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 65-12
In Commercial Distribution

  • D801ID6512I1 ()
65-12

  • Dentine adhesive
3M™ ESPE™ Ketac™ Nano Light-Curing Glass Ionomer Quick Mix Capsule Shade A3, Sample, 3305A3-S
3M COMPANY
3305A3-S
In Commercial Distribution

  • 50605861039098 ()
  • 30605861039094 ()
  • 00605861039093 ()
3305A3-S

  • Glass ionomer dental cement
3M™ ESPE™ Ketac™ Nano Light-Curing Glass Ionomer Quick Mix Capsule Shade A3.5 Refill, 3305A3.5
3M COMPANY
3305A3.5
In Commercial Distribution

  • 50605861039050 ()
  • 30605861039056 ()
  • 00605861039055 ()
3305A3.5

  • Glass ionomer dental cement
3M™ ESPE™ Ketac™ Nano Light-Curing Glass Ionomer Quick Mix Capsule Shade A2 Refill, 3305A2
3M COMPANY
3305A2
In Commercial Distribution

  • 50605861039012 ()
  • 30605861039018 ()
  • 00605861039017 ()
3305A2

  • Glass ionomer dental cement
3M™ ESPE™ Ketac™ Nano Light-Curing Glass Ionomer Quick Mix Capsule Shade A4 Refill, 3305A4
3M COMPANY
3305A4
In Commercial Distribution

  • 50605861041435 ()
  • 30605861041431 ()
  • 00605861041430 ()
3305A4

  • Glass ionomer dental cement
3M™ ESPE™ Ketac™ Nano Light-Curing Glass Ionomer Quick Mix Capsule Shade B2 Refill, 3305B2
3M COMPANY
3305B2
In Commercial Distribution

  • 50605861039074 ()
  • 30605861039070 ()
  • 00605861039079 ()
3305B2

  • Glass ionomer dental cement
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