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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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The Renew® Finishing System is intended for use in the removal of composite paste after debonding and polishing of the surface of enamel, porcelain, metal or composite. This is the Latch Renew Finish Point.
RELIANCE ORTHODONTIC PRODUCTS INC
RSPL
In Commercial Distribution

  • D798RSPL1 ()
  • D798RSPL0 ()
RSPL

  • Polymeric dental bur
Intended for use as a Lingual Retainer Wire. Ortho Flex Tech® is best used for lower lingual 3 to 3 retainers and upper lingual 2 to 2 fixed retainers. This is 14karat White Gold
RELIANCE ORTHODONTIC PRODUCTS INC
OFT2
In Commercial Distribution

  • D798OFT20 ()
OFT2

  • Orthodontic retainer
INDICATIONS FOR USE: Custom IQ™ is intended for use as a chair-side, fast set, no mix chemical cure bonding resin for custom base indirect bonding. This is Part B of the two part system
RELIANCE ORTHODONTIC PRODUCTS INC
CIQB
Not in Commercial Distribution

  • D798CIQB0 ()
CIQB

  • Dentine bonding agent/set
The Morales Protraction Facemask is intended as an efficient extraoral appliance in moving skeletal Class III maxilla forward and stabilizing or retracting the mandible. It is also effective in closing space and correcting negative overjet.
Ortosim, S.A. de C.V.
Plus
In Commercial Distribution

  • D864PLUS0 ()


  • Orthodontic extraoral headgear
The Morales Protraction Facemask is intended as an efficient extraoral appliance in moving skeletal Class III maxilla forward and stabilizing or retracting the mandible. It is also effective in closing space and correcting negative overjet.
Ortosim, S.A. de C.V.
Mini
In Commercial Distribution

  • D864MINI0 ()


  • Orthodontic extraoral headgear
The Morales Protraction Facemask is intended as an efficient extraoral appliance in moving skeletal Class III maxilla forward and stabilizing or retracting the mandible. It is also effective in closing space and correcting negative overjet.
Ortosim, S.A. de C.V.
Ecotropic
In Commercial Distribution

  • D864ECOTROPIC0 ()


  • Orthodontic extraoral headgear
The Morales Protraction Facemask is intended as an efficient extraoral appliance in moving skeletal Class III maxilla forward and stabilizing or retracting the mandible. It is also effective in closing space and correcting negative overjet.
Ortosim, S.A. de C.V.
Eco
In Commercial Distribution

  • D864ECO0 ()


  • Orthodontic extraoral headgear
A sterile tube-like device intended to facilitate the use of an open-surgery ligature loop ligator by guiding and protecting its passage through other tissues. It is made of plastic materials. This is a single-use device.
SENTREHEART, INC
Long
In Commercial Distribution

  • M95560020 ()

  • Length: 22.5 Centimeter
6002

  • Open-surgery ligator guide sheath
A sterile tube-like device intended to facilitate the use of an open-surgery ligature loop ligator by guiding and protecting its passage through other tissues. It is made of plastic materials. This is a single-use device.
ATRICURE, INC.
Long
In Commercial Distribution

  • 00818354017601 ()
  • M95560020 ()
6002

  • Suture cutter, single-use
The SURFIX® hexagonal screwdriver is used to mill the bone to introduce the collar of the screw and to screw screws and lock screws. It is also used to remove screws and lock screws.
NEWDEAL
MA004ND
In Commercial Distribution

  • M248MA004ND1 ()
  • 10381780052357 ()

  • 3.49mm 6 pans; 215mm total length


  • Surgical screwdriver, reusable
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