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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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Alpha II® AP is a radiopaque fluoride containing light-cure micro-hybrid restorative composite. The special combination of fillers form a material that is extremely durable and wear-resistant; making it ideal for Class I and II restorations yet highly polishable for use in all Class III, IV and V restorations. Alpha II® AP has optimal handling characteristics. The material can be easily manipulated without sticking to your instruments. Alpha II® contains fluorescence to provide a duplication of the natural tooth surface. Kit contains: 3 x 4g Composite Syringe, 1 x 4g Alpha-Etch®, 3ml Alpha-Bond®, Brushes, Applicator Tips, Dispensing Pad
DENTAL TECHNOLOGIES, INC.
102.0008.002
In Commercial Distribution

  • D73510200080020 ()
102.0008.002

  • Dental composite resin
Electronic unit for identifying the localised haemorrhoidal arteries by means of acoustic signals. Part of the A.M.I. HAL/RAR System. The A.M.I. HAL-II Electronic System is a Doppler-based device. It is powered by a DC voltage source (rechargeable batteries or 12 V adapter). The A.M.I. HAL-II Electronic System generates electrical signals, calculates differences between the wavelength of outgoing and reflected electrical signals, and generates an acoustic Doppler signal. Together with auxiliary A.M.I. devices (A.M.I. HAL Handle, Probe and Sleeve) the A.M.I. HAL-II Electronic System serves for the detection of haemorrhoidal arteries and enables manual ligation of detected arteries, as well as mucopexy of prolapsing haemorrhoidal mucosa.
AMI Agency for Medical Innovations GmbH
AHE 203
Not in Commercial Distribution

  • EAMIAHE2030 ()

  • Weight: 3.2 Kilogram
  • Depth: 260 Millimeter
  • Height: 140 Millimeter
  • Width: 385 Millimeter
AHE 203

  • Noninvasive vascular ultrasound system
L-SHA-Light Cured Nano Particle Paint-On Restorative and Veneer Cement (Flowable Composite) L-SHA is recommended for cementing fabricated laminate veneers, restoring acrylic veneers and for use in Class III and Class V restorations, and for limited use in Class I restorations in premolars, and selected Class IV restorations where aesthetics are of primary importance. OUTSTANDING FEATURES OF THE MATERIAL High adhesive strength to etched enamel without the use of bonding agents. Superior aesthetics due to well balanced opacity and light reflectance. Excellent color stability. Reduced oxygen inhibited layer contributes to the ease of finishing. Does not require refrigeration. Shelf life in excess of two years. Fast in application–one component restorative system. Excellent flow of the material facilitates application. May be cured with any dentalcuring instrument operating in the visible range.
DENT ZAR, INC.
1008
In Commercial Distribution

  • D83610081 ()
1008

  • Dental composite resin
L-SHA-Light Cured Nano Particle Paint-On Restorative and Veneer Cement (Flowable Composite) L-SHA is recommended for cementing fabricated laminate veneers, restoring acrylic veneers and for use in Class III and Class V restorations, and for limited use in Class I restorations in premolars, and selected Class IV restorations where aesthetics are of primary importance. OUTSTANDING FEATURES OF THE MATERIAL High adhesive strength to etched enamel without the use of bonding agents. Superior aesthetics due to well balanced opacity and light reflectance. Excellent color stability. Reduced oxygen inhibited layer contributes to the ease of finishing. Does not require refrigeration. Shelf life in excess of two years. Fast in application–one component restorative system. Excellent flow of the material facilitates application. May be cured with any dentalcuring instrument operating in the visible range.
DENT ZAR, INC.
0039
In Commercial Distribution

  • D83600390 ()
0039

  • Dental composite resin
L-SHA-Light Cured Nano Particle Paint-On Restorative and Veneer Cement (Flowable Composite) L-SHA is recommended for cementing fabricated laminate veneers, restoring acrylic veneers and for use in Class III and Class V restorations, and for limited use in Class I restorations in premolars, and selected Class IV restorations where aesthetics are of primary importance. OUTSTANDING FEATURES OF THE MATERIAL High adhesive strength to etched enamel without the use of bonding agents. Superior aesthetics due to well balanced opacity and light reflectance. Excellent color stability. Reduced oxygen inhibited layer contributes to the ease of finishing. Does not require refrigeration. Shelf life in excess of two years. Fast in application–one component restorative system. Excellent flow of the material facilitates application. May be cured with any dentalcuring instrument operating in the visible range.
DENT ZAR, INC.
0038
In Commercial Distribution

  • D83600380 ()
0038

  • Dental composite resin
L-SHA-Light Cured Nano Particle Paint-On Restorative and Veneer Cement (Flowable Composite) L-SHA is recommended for cementing fabricated laminate veneers, restoring acrylic veneers and for use in Class III and Class V restorations, and for limited use in Class I restorations in premolars, and selected Class IV restorations where aesthetics are of primary importance. OUTSTANDING FEATURES OF THE MATERIAL High adhesive strength to etched enamel without the use of bonding agents. Superior aesthetics due to well balanced opacity and light reflectance. Excellent color stability. Reduced oxygen inhibited layer contributes to the ease of finishing. Does not require refrigeration. Shelf life in excess of two years. Fast in application–one component restorative system. Excellent flow of the material facilitates application. May be cured with any dentalcuring instrument operating in the visible range.
DENT ZAR, INC.
0037
In Commercial Distribution

  • D83600370 ()
0037

  • Dental composite resin
L-SHA-Light Cured Nano Particle Paint-On Restorative and Veneer Cement (Flowable Composite) L-SHA is recommended for cementing fabricated laminate veneers, restoring acrylic veneers and for use in Class III and Class V restorations, and for limited use in Class I restorations in premolars, and selected Class IV restorations where aesthetics are of primary importance. OUTSTANDING FEATURES OF THE MATERIAL High adhesive strength to etched enamel without the use of bonding agents. Superior aesthetics due to well balanced opacity and light reflectance. Excellent color stability. Reduced oxygen inhibited layer contributes to the ease of finishing. Does not require refrigeration. Shelf life in excess of two years. Fast in application–one component restorative system. Excellent flow of the material facilitates application. May be cured with any dentalcuring instrument operating in the visible range.
DENT ZAR, INC.
0036
In Commercial Distribution

  • D83600360 ()
0036

  • Dental composite resin
L-SHA-Light Cured Nano Particle Paint-On Restorative and Veneer Cement (Flowable Composite) L-SHA is recommended for cementing fabricated laminate veneers, restoring acrylic veneers and for use in Class III and Class V restorations, and for limited use in Class I restorations in premolars, and selected Class IV restorations where aesthetics are of primary importance. OUTSTANDING FEATURES OF THE MATERIAL High adhesive strength to etched enamel without the use of bonding agents. Superior aesthetics due to well balanced opacity and light reflectance. Excellent color stability. Reduced oxygen inhibited layer contributes to the ease of finishing. Does not require refrigeration. Shelf life in excess of two years. Fast in application–one component restorative system. Excellent flow of the material facilitates application. May be cured with any dentalcuring instrument operating in the visible range.
DENT ZAR, INC.
0035
In Commercial Distribution

  • D83600350 ()
0035

  • Dental composite resin
L-SHA-Light Cured Nano Particle Paint-On Restorative and Veneer Cement (Flowable Composite) L-SHA is recommended for cementing fabricated laminate veneers, restoring acrylic veneers and for use in Class III and Class V restorations, and for limited use in Class I restorations in premolars, and selected Class IV restorations where aesthetics are of primary importance. OUTSTANDING FEATURES OF THE MATERIAL High adhesive strength to etched enamel without the use of bonding agents. Superior aesthetics due to well balanced opacity and light reflectance. Excellent color stability. Reduced oxygen inhibited layer contributes to the ease of finishing. Does not require refrigeration. Shelf life in excess of two years. Fast in application–one component restorative system. Excellent flow of the material facilitates application. May be cured with any dentalcuring instrument operating in the visible range.
DENT ZAR, INC.
0034
In Commercial Distribution

  • D83600340 ()
0034

  • Dental composite resin
The Snap & Sniff® threshold test system was developed to provide scientists, clinicians, and others with a standardized, easy-to- use, and reliable means for assessing odor detection thresholds. In its standard form, the test employs the odorant phenyl ethyl alcohol (PEA), a stimulus with a rose-like smell at higher concentrations and little or no intranasal trigeminal nerve (CN V) reactivity. Other odorants, including n- butanol, ethyl acetate, guaiacol, pentyl (amyl) acetate, and phenyl ethyl methyl ethyl carbinol, are also available from Sensonics on a custom basis. The Snap & Sniff® threshold test kit is comprised of 20 smell “wands”. Five of these wands contain no odor, whereas the other wands contain, in the case of the standard odorant phenyl ethyl alcohol, half-log stimulus dilutions ranging from 10-2 (strongest) to 10-9 (weakest) concentrations. The odor of a given wand is contained within a cartridge similar to that of a felt-tip pen. When the thumb of the operator pushes forward on a slide mechanism, the odorized tip is exposed for sampling and presented to the subject. Releasing the slide retracts the odorized tip back into the wand’s housing. The Snap & Sniff® mechanism results in an easy presentation of an odorant to a subject. Because the odorant tip is presented only briefly, the odor is retained for much longer periods and can be used for testing many more subjects than devices lacking such sophisticated technology.
Sensonics, Inc.
SST
In Commercial Distribution

  • G051SST0 ()


  • Olfactory test stick
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