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+ 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
SureFil® SDR® flow Posterior Bulk Fill Flowable Base Universal Syringe Sampler
DENTSPLY INTERNATIONAL INC.
61C004
Not in Commercial Distribution

  • D00261C0041 ()

  • 1 half-filled SureFil SDR Flow Universal syringe and 3 mix tips
  • Weight: 0.5 Gram
61C004

  • Dental composite resin
Aquasil® Ultra+ XLV Fast Set Small digit® 50 pack
DENTSPLY INTERNATIONAL INC.
678645
In Commercial Distribution

  • D0026786451 ()
  • D0026786450 ()

  • 50 (1.6mL) Small Unit Doses, 50 Mix Tips, 50 Intraoral Tips
  • Total Volume: 1.6 Milliliter
678645

  • Silicone dental impression material
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
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
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
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
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
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
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
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
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
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
3M™ ESPE™ Ketac™ Nano Light-Curing Glass Ionomer Quick Mix Capsule Shade A1 Refill, 3305A1
3M COMPANY
3305A1
In Commercial Distribution

  • 50605861012091 ()
  • 30605861012097 ()
  • 00605861012096 ()
3305A1

  • 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 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 B2 Refill, 3305B2
3M COMPANY
3305B2
In Commercial Distribution

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

  • 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 A3 Refill, 3305A3
3M COMPANY
3305A3
In Commercial Distribution

  • 50605861039036 ()
  • 30605861039032 ()
  • 00605861039031 ()
3305A3

  • 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
No Description
Axiodent Inc.
19020 Manual Mix Pack
In Commercial Distribution

  • D161190200 ()


  • Calcium hydroxide dental cement
No Description
Axiodent Inc.
19009 Manual Mix Pack
In Commercial Distribution

  • D161190090 ()


  • Calcium hydroxide dental cement
No Description
Axiodent Inc.
25016 Manual Mix Pack
In Commercial Distribution

  • D161250160 ()


  • Calcium hydroxide dental cement
ORTHODONTIC GLITTER
LANG DENTAL MANUFACTURING CO., INC.
28 GRAMS SILVER MIX
In Commercial Distribution

  • D6502410SM0 ()
2410SM

  • Dental prosthesis restorative material, unfilled resin
No Description
BIOMET
418300
In Commercial Distribution

  • 00880304371002 ()

  • 120G
418300

  • Orthopaedic cement preparation/delivery kit
No Description
BIOMET
418200
In Commercial Distribution

  • 00880304370999 ()

  • 80G
418200

  • Orthopaedic cement preparation/delivery kit
No Description
BIOMET
417300
In Commercial Distribution

  • 00880304370623 ()

  • 120G
417300

  • Orthopaedic cement preparation/delivery kit
No Description
BIOMET
417200
In Commercial Distribution

  • 00880304370609 ()

  • 80G
417200

  • Orthopaedic cement preparation/delivery kit
No Description
BIOMET
417100
In Commercial Distribution

  • 00880304370579 ()

  • 40G
417100

  • Orthopaedic cement preparation/delivery kit
No Description
BURKHART DENTAL SUPPLY CO., THE
72720806
In Commercial Distribution

  • 00854212006981 ()
  • 00854212006974 ()


  • Dental material mixing nozzle
Genotyping system for the detection of Factor II (Prothrombin) G20210A mutations.
AUTOGENOMICS, INC
01-3020-01
Not in Commercial Distribution

  • 00850009370068 ()
01-3020-01

  • Coagulation factor II (prothrombin) mutation IVD, kit, nucleic acid technique (NAT)
No Description
Lonza Verviers
BESP698P1/0.5
In Commercial Distribution

  • 05407010126976 ()
BESP698P1/0.5

  • Ex vivo cell culture medium
No Description
BIOARRAY SOLUTIONS LTD
800-00194
In Commercial Distribution

  • 10888234100669 ()
800-00194

  • Multiple blood group genotyping IVD, reagent
No Description
SEPTODONT, INC
FP-NOVOINC-054
In Commercial Distribution

  • 07540187001061 ()


  • Orthodontic bracket adhesive
Silcone Dental Impression Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
275380
In Commercial Distribution

  • 07540172008105 ()

  • cartridge
  • Total Volume: 380 Milliliter
275380

  • Silicone dental impression material
No Description
Sarstedt Aktiengesellschaft & Co.KG
65.716.399
In Commercial Distribution

  • 04038917925648 ()
  • 04038917925624 ()
65.716.399

  • Test tube/reservoir cap IVD
No Description
BISCO INC.
F-6102D
Not in Commercial Distribution

  • D757F6102D1 ()

  • sixe text
F-6102D

  • Dentine bonding agent/set
No Description
BISCO INC.
F-6101D
Not in Commercial Distribution

  • D757F6101D1 ()

  • sixe text
F-6101D

  • Dentine bonding agent/set
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