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 digit LV & XLV Regular Set Evaluator Kit
DENTSPLY INTERNATIONAL INC.
678031
Not in Commercial Distribution

  • D0026780311 ()
678031

  • Silicone dental impression material
DSQ Alert™ HT Candida auris Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences within the ITS2 gene of Candida auris. The mix consists of a total of 3.9 nmol of probe per vial in a 1X TE buffer solution. The probe is labeled with FAM and has an excitation wavelength maxima of 496 nm and an emission wavelength maxima of 517 nm.
Elitechgroup Mdx LLC
M800761
In Commercial Distribution

  • 03661540952579 ()


  • Candida auris nucleic acid IVD, kit, nucleic acid technique (NAT)
3M™ Impregum™ Penta™ Super Quick MB Introductory Kit Dual, 69414
3M Deutschland GmbH
69414
In Commercial Distribution

  • 04054596582620 ()
69414

  • Dental material mixing nozzle
  • Gingival retraction kit
  • Dental material injection cannula, single-use
  • Polyether dental impression material
  • Dental impression material adhesive
  • Dental impression material mixer
3M™ Impregum™ Penta™ Super Quick HB/LB Introductory Kit Dual, 69407
3M Deutschland GmbH
69407
In Commercial Distribution

  • 04054596582514 ()
69407

  • Gingival retraction kit
  • Dental material injection cannula, single-use
  • Polyether dental impression material
  • Dental impression material adhesive
  • Dental impression material mixer
  • Dental material mixing nozzle
3M™ Impregum™ Penta™ Super Quick MB/LB Introductory Kit Dual, 69415
3M Deutschland GmbH
69415
In Commercial Distribution

  • 04054596582477 ()
69415

  • Dental material injection cannula, single-use
  • Dental impression material adhesive
  • Dental material mixing nozzle
  • Polyether dental impression material
  • Dental impression material mixer
  • Gingival retraction kit
INDICATIONS FOR USE: Custom IQ™ is intended for use as a chair-side, fast set, no mix chemical cure bonding resin for custom base indirect bonding. This is Part B of the two part system
RELIANCE ORTHODONTIC PRODUCTS INC
CIQB
Not in Commercial Distribution

  • D798CIQB0 ()
CIQB

  • Dentine bonding agent/set
INDICATIONS FOR USE: Custom IQ™ is intended for use as a chair-side, fast set, no mix chemical cure bonding resin for custom base indirect bonding. This is the Part A of the two part system.
RELIANCE ORTHODONTIC PRODUCTS INC
CIQA
Not in Commercial Distribution

  • D798CIQA0 ()
CIQA

  • Dentine bonding agent/set
Heat Stress First Aid Kit, Plastic Case - Contains: Cold Pack, 4" x 5" (4); Disposable Thermometer (5); Electrolyte Drink Mix (10); Electrolyte Tablets (50); Emergency Blanket, 52" x 84"; Waterproof Tape, 1/2" X 5yd (2),
Acme United Corporation
5250
In Commercial Distribution

  • 00738743052504 ()
5250

  • First aid kit, non-medicated, reusable
CROWN AND BRIDGE MIXING TIP (25/pack) Type: T-Mixer Fine, Ratio: 10:1; For more information: https://www.scottsdental.com/catalog/product/view/id/17354/s/temporary-crown-bridge-mixing-tips-scott-s-select/
SCOTT'S DENTAL SUPPLY L.L.C.
104-8110
In Commercial Distribution

  • D77810481100 ()
  • D77810481101 ()
104-8110

  • Dental material mixing nozzle
Mixing tips 45 pcs. Mixing tips used for dispensing material from auto mix cartridges for Instatemp Max composite, a tooth colored bis-acryl composite used to fabricate temporary crowns and bridges, long-term temporaries, provisional inlays, onlays and veneers.
STERNGOLD DENTAL LLC
220220
In Commercial Distribution

  • 00841549115981 ()


  • Dental material mixing nozzle
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