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-003
In Commercial Distribution

  • D767B0103081 ()
  • D767B010301 ()
B01-0308

  • 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-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
Square ultrafit sheets .060" 50-pack
DENTSPLY SIRONA ORTHODONTICS INC.
UFS060X50S
Not in Commercial Distribution

  • D746UFS060X50S1 ()
  • D746UFS060X50S0 ()
UFS060X50S

  • Dental implant x-ray template
Round ultrafit sheets .060" 50-pack
DENTSPLY SIRONA ORTHODONTICS INC.
UFS060X50R
Not in Commercial Distribution

  • D746UFS060X50R1 ()
  • D746UFS060X50R0 ()
UFS060X50R

  • Dental implant x-ray template
Square ultrafit sheets .060" 25-pack
DENTSPLY SIRONA ORTHODONTICS INC.
UFS060X25S
Not in Commercial Distribution

  • D746UFS060X25S1 ()
  • D746UFS060X25S0 ()
UFS060X25S

  • Dental implant x-ray template
Round ultrafit sheets .060"x125mm. 25-pack
DENTSPLY SIRONA ORTHODONTICS INC.
UFS060X25R
Not in Commercial Distribution

  • D746UFS060X25R1 ()
  • D746UFS060X25R0 ()
UFS060X25R

  • Dental implant x-ray template
Square ultrafit sheets .040" 10-pack small
DENTSPLY SIRONA ORTHODONTICS INC.
UFS040X10SS
Not in Commercial Distribution

  • D746UFS040X10SS1 ()
  • D746UFS040X10SS0 ()
UFS040X10SS

  • Dental implant x-ray template
Round ultrafit sheets .040"x125mm. 10-pack
DENTSPLY SIRONA ORTHODONTICS INC.
UFS040X10R
Not in Commercial Distribution

  • D746UFS040X10R1 ()
  • D746UFS040X10R0 ()
UFS040X10R

  • Dental implant x-ray template
Square ultrafit sheets .040" 100-pack small
DENTSPLY SIRONA ORTHODONTICS INC.
UFS040X100SS
Not in Commercial Distribution

  • D746UFS040X100SS1 ()
  • D746UFS040X100SS0 ()
UFS040X100SS

  • Dental implant x-ray template
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