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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Whip Mix VeriGuide™ OS is a 3D printed resin for producing drilling guides used in dental surgery.
WHIP-MIX CORPORATION
71175
In Commercial Distribution

  • D040711751 ()
71175

  • Custom-made orthopaedic/craniofacial surgical guide
Aquasil Ultra+ Tray Material Hand Mix Soft Putty Regular Set (Orange) with 50mL LV Regular Set Wash Material
DENTSPLY INTERNATIONAL INC.
678712
Not in Commercial Distribution

  • D0026787121 ()
678712

  • Silicone dental impression material
Aquasil Ultra+ Tray Material Hand Mix Soft Putty Regular Set (Teal) with 50mL XLV Regular Set Wash Material
DENTSPLY INTERNATIONAL INC.
678711
Not in Commercial Distribution

  • D0026787111 ()
678711

  • Silicone dental impression material
Self Mixing Tips are intended for use in the mix / delivery of two part adhesives/cements. Qty 15
RELIANCE ORTHODONTIC PRODUCTS INC
SMT
In Commercial Distribution

  • D798SMT1 ()
  • D798SMT0 ()
SMT

  • Dental material injection cannula, single-use
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix. Paste / Liquid. Syringe. Non-Boxed.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 66-02
In Commercial Distribution

  • D801SP66021 ()
66-02

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

  • D801SP6512S1 ()
65-12

  • Dentine adhesive
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Activator / Primer. Non-Boxed.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-121 N
In Commercial Distribution

  • D801SP65121N1 ()
65-121

  • Dentine adhesive
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Activator / Primer. Boxed.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-121 B
In Commercial Distribution

  • D801SP65121B1 ()
65-121

  • Dentine adhesive
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Part B. Carpule.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-028 C
In Commercial Distribution

  • D801SP65028C1 ()
65-028

  • Dentine adhesive
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Part B. Boxed.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-024 B
In Commercial Distribution

  • D801SP65024B1 ()
65-024

  • Dentine adhesive
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Part B. Non-Boxed.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-024
In Commercial Distribution

  • D801SP650241 ()
65-024

  • Dentine adhesive
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Part B. Boxed.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-022 B
In Commercial Distribution

  • D801SP65022B1 ()
65-022

  • Dentine adhesive
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Part B. Boxed.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-022
In Commercial Distribution

  • D801SP650221 ()
65-022

  • Dentine adhesive
3M™ ESPE™ Ketac™ Nano Light-Curing Glass Ionomer Quick Mix Capsule Shade A1 Sample Kit, 3305A1-S
3M COMPANY
3305A1-S
Not in Commercial Distribution

  • 50605861005451 ()
  • 30605861005457 ()
  • 00605861005456 ()
3305A1-S

  • Glass ionomer dental cement
A device used to mix the powder and liquid in application capsules intended for use in dental treatments.
E.M.S. Electro Medical Systems (Hangzhou)Co.,Ltd.
A
In Commercial Distribution

  • 06971503860788 ()
Y200F6D490 9050

  • Dental amalgam mixer
The MGB Alert One-Step Reverse Transcriptase PCR Master Mix package includes a 2X master mix containing a thermostable polymerase with exonuclease activity and provided in hot-start format. Included are 100X reverse transcriptase, 50X RNase inhibitor, and RNase-free water in separate tubes.
Elitechgroup Mdx LLC
M800689
In Commercial Distribution

  • 03661540951756 ()
M800689

  • Nucleic acid amplification mastermix kit IVD
oncoReveal CDx Box 2 of 4. This box contains all of the indexing primers and indexing PCR master mix.
Pillar Biosciences, Inc.
HDA-LC-2001-48-2
In Commercial Distribution

  • 00860001218237 ()
HDA-LC-2001-48-2

  • Colorectal cancer genotyping IVD, kit, nucleic acid technique (NAT)
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix. Paste / Liquid. Syringe. Non-Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 66-02 I
In Commercial Distribution

  • D801ID6602I1 ()
66-02

  • Dentine adhesive
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix. Paste / Liquid. Syringe. Non-Boxed. Spanish.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 66-02 S
In Commercial Distribution

  • D801SP6602S1 ()
66-02

  • Dentine adhesive
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Activator / Primer Plastic Bottle. Boxed.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-126 B
In Commercial Distribution

  • D801SP65126B1 ()
65-126

  • Dentine adhesive
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Activator / Primer Plastic Bottle. Non-Boxed.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-126
In Commercial Distribution

  • D801SP651261 ()
65-126

  • Dentine adhesive
No Description
Dentsply International Inc.
644432
In Commercial Distribution

  • D0016444321 ()
644432

  • Solution agitator
  • Root canal ultrasonic irrigation handpiece tip
  • Medical equipment/instrument drape, single-use
No Description
Dentsply International Inc.
644431
In Commercial Distribution

  • D0016444311 ()
644431

  • Medical equipment/instrument drape, single-use
  • Root canal ultrasonic irrigation handpiece tip
  • Solution agitator
No Description
Lonza Verviers
BESP808X10
Not in Commercial Distribution

  • 05407010124507 ()
BESP808X10

  • Ex vivo cell culture medium
No Description
Lonza Verviers
BESP808X5
In Commercial Distribution

  • 05407010121612 ()
BESP808X5

  • Ex vivo cell culture medium
No Description
Lonza Verviers
BESP808J
In Commercial Distribution

  • 05407010121599 ()
BESP808J

  • Ex vivo cell culture medium
No Description
Lonza Verviers
BESP698P20S
In Commercial Distribution

  • 05407010126983 ()
BESP698P20S

  • Ex vivo cell culture medium
No Description
Lonza Verviers
BESP808X0.365
In Commercial Distribution

  • 05407010121605 ()
BESP808X0.365

  • Ex vivo cell culture medium
No Description
Lonza Verviers
BESP808D
In Commercial Distribution

  • 05407010121582 ()
BESP808D

  • Ex vivo cell culture medium
No Description
Lonza Verviers
BESP808B1
In Commercial Distribution

  • 05407010121575 ()
BESP808B1

  • Ex vivo cell culture medium
No Description
Lonza Verviers
BESP808B0.5
In Commercial Distribution

  • 05407010121568 ()
BESP808B0.5

  • Ex vivo cell culture medium
Glass Ionomer Cement For Orthodontic Bands-Blue Color
ORTHO SPECIALTIES
600-400
In Commercial Distribution

  • 00842452100583 ()
600-400

  • Orthodontic bracket adhesive
Glass Ionomer Cement For Orthodontic Bands-Natural Color
ORTHO SPECIALTIES
600-401
In Commercial Distribution

  • 00842452100590 ()
600-401

  • Orthodontic bracket adhesive
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 215b-1010 P
Not in Commercial Distribution

  • 04049016053248 ()


  • Legionella pneumophila total antibody IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 215b-1003 P
Not in Commercial Distribution

  • 04049016053224 ()


  • Legionella pneumophila total antibody IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 215b-2005 P
Not in Commercial Distribution

  • 04049016053255 ()


  • Legionella pneumophila total antibody IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 215b-1005 P
Not in Commercial Distribution

  • 04049016053231 ()


  • Legionella pneumophila total antibody IVD, kit, fluorescent immunoassay
Genotyping system for the detection of Factor II (Prothrombin) G20210A and Factor V Leiden G1691A mutations
AUTOGENOMICS, INC
01-3050-01
Not in Commercial Distribution

  • 00850009370129 ()
01-3050-01

  • Inherited thrombophilia IVD, kit, nucleic acid technique (NAT)
Genotyping systme for the detection of the Factor V Leiden G1691A mutation
AUTOGENOMICS, INC
01-3030-01
Not in Commercial Distribution

  • 00850009370099 ()
01-3030-01

  • Inherited thrombophilia IVD, kit, nucleic acid technique (NAT)
VPS Impression Tray Material
DEN-MAT HOLDINGS, LLC
012381
In Commercial Distribution

  • 00359883006525 ()

  • Total Volume: 380 Milliliter
012381

  • Silicone dental impression material
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