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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A device consisting of a material such as plastic resin that is intended to be applied as a permanent coating or lining on the base or tissue-contacting surface of a denture for improved fitting. It is available [non-prescription] over-the-counter (OTC) and will enable the user to make a permanent adjustment without professional assistance. Denture relining is defined as a process of providing a new fitting surface to a denture (ISO 1942-2, def 2.111). After application, this device cannot be reused.
PERMA LABORATORIES LLC
2ps
In Commercial Distribution

  • 00852305002018 ()


  • Denture reliner, soft, home-use
A device consisting of a material such as plastic resin that is intended to be applied as a permanent coating or lining on the base or tissue-contacting surface of a denture for improved fitting. It is available [non-prescription] over-the-counter (OTC) and will enable the user to make a permanent adjustment without professional assistance. Denture relining is defined as a process of providing a new fitting surface to a denture (ISO 1942-2, def 2.111). After application, this device cannot be reused.
PERMA LABORATORIES LLC
4c
In Commercial Distribution

  • 00852305002070 ()


  • Denture reliner, soft, home-use
The device is a temporary OTC soft, clear denture reliner consisting of 2 parts (1) a monomer liquid and (2) a polymer powder which are mixed together prior to application. This results in a plastic resin paste which is then applied to the denture plate and set in the mouth to cure for a short period of time. Once setting is complete, the excess soft material is able to be trimmed by an enclosed spatula. The application is completely reversible by soaking the denture plate overnight in an over the counter solution of hydrogen peroxide and then removing it by hand.
Doc Brands, Inc.
1
In Commercial Distribution

  • 00372494101960 ()


  • Denture reliner, soft, home-use
The device is a temporary OTC soft, clear denture reliner consisting of 2 parts (1) a monomer liquid and (2) a polymer powder which are mixed together prior to application. This results in a plastic resin paste which is then applied to the denture plate and set in the mouth to cure for a short period of time. Once setting is complete, the excess soft material is able to be trimmed by an enclosed spatula. The application is completely reversible by soaking the denture plate overnight in an over the counter solution of hydrogen peroxide and then removing it by hand.
MAJESTIC DRUG CO. INC.
1
In Commercial Distribution

  • 00010705400968 ()
  • 50010705400963 ()
  • 30010705400969 ()
  • 40010705400966 ()
  • 20010705400962 ()


  • Denture reliner, soft, home-use
JUSTI DENTURE RELINER SEMI RGD 1-OZ LIQUID&POWDER
AMERICAN TOOTH INDUSTRIES
072-14-0010
In Commercial Distribution

  • D772ATI1400100 ()


  • Denture reliner, soft, home-use
JUSTI DENTURE RELINER V/SOFT 1-OZ LIQUID&POWDERS
AMERICAN TOOTH INDUSTRIES
072-14-0009
In Commercial Distribution

  • D772ATI1400090 ()


  • Denture reliner, soft, home-use
JUSTI DENTURE RELINER SOFT 1-OZ LIQUID&POWDER
AMERICAN TOOTH INDUSTRIES
072-14-0008
In Commercial Distribution

  • D772ATI1400080 ()


  • Denture reliner, soft, home-use
JUSTI DENTURE RELINER POWDEER 1LB
AMERICAN TOOTH INDUSTRIES
072-14-0007
In Commercial Distribution

  • D772ATI1400070 ()


  • Denture reliner, soft, home-use
JUSTI DENTURE RELINER 8OZ V/SFT LIQUID
AMERICAN TOOTH INDUSTRIES
072-14-0006
In Commercial Distribution

  • D772ATI1400060 ()


  • Denture reliner, soft, home-use
JUSTI DENTURE RELINER 8OZ SOFT LIQUID
AMERICAN TOOTH INDUSTRIES
072-14-0005
In Commercial Distribution

  • D772ATI1400050 ()


  • Denture reliner, soft, home-use
JUSTI DENTURE RELINER 8 OZ LIQUID S/RGD
AMERICAN TOOTH INDUSTRIES
072-0004
In Commercial Distribution

  • D772ATI1400040 ()


  • Denture reliner, soft, home-use
JUSTI DENTURE RELINER KIT VERY SOFT
AMERICAN TOOTH INDUSTRIES
072-14-0003
In Commercial Distribution

  • D772ATI1400030 ()


  • Denture reliner, soft, home-use
JUSTI DENTURE RELINER KIT SOFT
AMERICAN TOOTH INDUSTRIES
072-14-0002
In Commercial Distribution

  • D772ATI1400020 ()


  • Denture reliner, soft, home-use
JUSTI DENTURE RELINER KIT SEMI-RGD
AMERICAN TOOTH INDUSTRIES
072-14-0001
In Commercial Distribution

  • D772ATI1400010 ()


  • Denture reliner, soft, home-use
JAZZ HP GREEN STATE POLISHER GS1S MEDIUM CONTOUR KNIFE EDGE 5X0.3MM - 4 PACK
Ss White Burs, Inc.
U89184
In Commercial Distribution

  • D690891840 ()
  • D690891842 ()
89184

  • Dental abrasive point, single-use
Bleeding Control Pack Intermediate - Texas State Act (H.B. No. 496) 4 Kits/Multipack
BOUND TREE MEDICAL, LLC
670184-KIT
In Commercial Distribution

  • 00812277035766 ()
  • 00810094571221 ()
670184-KIT

  • First aid kit, non-medicated, single-use
6.5MM X 45MM HEADED CANNULATED SCREW 30MM THREAD
ORTHO SOLUTIONS HOLDINGS LIMITED
OS914045-NS
Not in Commercial Distribution

  • 05055662950458 ()
OS914045-NS

  • Stress-therapy vibroacoustic headband
ITN Implant is a stainless steel bone screw
Exsomed Corporation
EXITN924575
Not in Commercial Distribution

  • B487EXITN9245750 ()

  • Length: 75 Millimeter
  • Outer Diameter: 4.5 Millimeter
EXITN924575

  • Stress-therapy vibroacoustic headband
ITN Implant is a stainless steel bone screw
Exsomed Corporation
EXITN924565
Not in Commercial Distribution

  • B487EXITN9245650 ()

  • Length: 65 Millimeter
  • Outer Diameter: 4.5 Millimeter
EXITN924565

  • Stress-therapy vibroacoustic headband
ITN Implant is a stainless steel bone screw
Exsomed Corporation
EXITN924555
Not in Commercial Distribution

  • B487EXITN9245550 ()

  • Length: 55 Millimeter
  • Outer Diameter: 4.5 Millimeter
EXITN924555

  • Stress-therapy vibroacoustic headband
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