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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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BenaCel® dental dressing is made of biocompatible oxidized cellulose and contains no chemical additives. BenaCel® dental dressing adheres to moist oral mucosa and forms a temporary barrier protecting the wound from further irritation and pain. When placed in the extraction socket, BenaCel® dental dressing forms a gelatinous scaffold in the blood extrude, facilitating the development of a stable blood clot to prevent dry socket formation. BenaCel® dental dressing is designed for use in the extraction site and the management of bleeding and alveolar osteitis (dry socket). It may also be used as a wound dressing for the temporary management of oral surgical wounds, such as operative, postoperative, donor sites and traumatic injuries.
UNICARE BIOMEDICAL INC.
C-002
In Commercial Distribution

  • D767B0102121 ()
  • D767B010201 ()
B01-0212

  • General oral wound dressing, non-animal-derived, sterile
BenaCel® dental dressing is made of biocompatible oxidized cellulose and contains no chemical additives. BenaCel® dental dressing adheres to moist oral mucosa and forms a temporary barrier protecting the wound from further irritation and pain. When placed in the extraction socket, BenaCel® dental dressing forms a gelatinous scaffold in the blood extrude, facilitating the development of a stable blood clot to prevent dry socket formation. BenaCel® dental dressing is designed for use in the extraction site and the management of bleeding and alveolar osteitis (dry socket). It may also be used as a wound dressing for the temporary management of oral surgical wounds, such as operative, postoperative, donor sites and traumatic injuries.
UNICARE BIOMEDICAL INC.
C-001
In Commercial Distribution

  • D767B0101081 ()
  • D767B010101 ()
B01-0108

  • General oral wound dressing, non-animal-derived, sterile
Non-sterile, non-implantable wound dressing
Keranetics, Inc.
00
In Commercial Distribution

  • B789P00211 ()
  • B789P00210 ()

  • Total Volume: 5 Milliliter


  • Skin semi-occlusive dressing, non-antimicrobial
Sterile, non-implantable, water-based gelatinous (hydrogel) wound dressing
Keranetics, Inc.
00
In Commercial Distribution

  • B789P00100 ()
  • B789P00101 ()

  • Total Volume: 5 Milliliter


  • Wound hydrogel dressing, non-antimicrobial
Canal Prep Root Canal Preparation Cream 18gm. - MARK3
CARGUS INTERNATIONAL, INC
5978
In Commercial Distribution

  • D79659780 ()


  • Root canal cleaning solution
SICAT OPTIMOTION
SiCAT GmbH & Co. KG
10501
In Commercial Distribution

  • D776105010 ()
10501

  • Custom-made mouthguard
Adjusting instrument
Sigma Instruments, Inc.
SA-201
In Commercial Distribution

  • B733KDYST0 ()


  • Joint/spinal manipulator, electronic
Adjusting instrument
Sigma Instruments, Inc.
SA-201
In Commercial Distribution

  • B733KDY20 ()


  • Joint/spinal manipulator, electronic
Adjusting instrument
Sigma Instruments, Inc.
SA-201
In Commercial Distribution

  • B733KDY10 ()


  • Joint/spinal manipulator, electronic
Maggot-impregnated gauze. Two 2" x 2" gauze pads impregnated with 250 - 500 disinfected larvae.
MONARCH LABS
250
In Commercial Distribution

  • B698MM2501 ()
MM250

  • Wound debridement maggot
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