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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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JUSTI DENTURE - D772ATI1400010

JUSTI DENTURE RELINER KIT SEMI-RGD
AMERICAN TOOTH INDUSTRIES
072-14-0001
In Commercial Distribution

  • D772ATI1400010 ()


  • Denture reliner, soft, home-use

EnSite™ - 05415067024909

Noise Reduction Transformer, 100V
ST. JUDE MEDICAL, INC.
H702490
In Commercial Distribution

  • 05415067024909 ()
H702490

  • Constant-voltage transformer

EnSite™ - 05415067024848

Noise Reduction Transformer, 120V
ST. JUDE MEDICAL, INC.
H702484
In Commercial Distribution

  • 05415067024848 ()
H702484

  • Constant-voltage transformer

EnSite™ - 05415067024831

Noise Reduction Transformer, 240V
ST. JUDE MEDICAL, INC.
H702483
In Commercial Distribution

  • 05415067024831 ()
H702483

  • Constant-voltage transformer

Perma Soft Denture Reliner - 00852305002070

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

ProSoft Professional Denture Reliner - 00852305002018

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

N/A - 04961333241392

ISOLATION TRANSFORMER 1200V 10A 4 OUTLETS
PENTAX OF AMERICA, INC.
90075
In Commercial Distribution

  • 04961333241392 ()


  • Constant-voltage transformer

N/A - 04961333230334

Isolation Transformer
PENTAX OF AMERICA, INC.
9175
In Commercial Distribution

  • 04961333230334 ()


  • Constant-voltage transformer

DenSureFit - 00863995000109

DenSureFit is an over-the-counter soft reline kit. It consists of 2 applicators of vinyl polysiloxane, 1 vial primer, 2 stick applicators and 1 IFU. The kit is intended to reline one denture plate. It is intended to provide temporary relief from ill-fitting dentures until a dentist can be seen.
OTC DENTAL CORPORATION
DSF212.00
In Commercial Distribution

  • 00863995000109 ()


  • Denture reliner, soft, home-use

WALL TRANSFORMER EN 200-1 - 04053755199686

No Description
Heine Optotechnik GmbH & Co. KG
000
In Commercial Distribution

  • 04053755199686 ()
X-095.12.252

  • Constant-voltage transformer
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