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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 Class Implantable

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ATOZ Expander Kit - 08800197900068

The ATOZ Expander Kit is a procedure kit used for orthodontic treatment and consists of an expander, screws, drivers, wires, and accessories. ATOZ Expander:MKE-08-F*1ea ATOZ Key: MK Key-L*1ea, MK Key-S*1ea ATOZ Mini-Screw: MKS-1611*2ea, MKS-1613*8ea ATOZ Screwdriver MKD-S *1ea, MKD-L*1ea ATOZ Tooth connecting arms: MK Wire arm-1240*4ea
MK Meditech Inc.
ATOZ Expander Kit
In Commercial Distribution

  • 08800197900068 ()


  • Surgical screwdriver, reusable
  • Orthodontic archwire
  • Orthodontic anchoring screw
  • Orthodontic palate expander/teeth aligner, bonded
  • Orthodontic palate expander screw key

Bioplate® - M3848133670

Compact Plus Kit Low Profile System
Bioplate, Inc.
81-3367
In Commercial Distribution

  • M3848133670 ()
81-3367

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
  • Craniofacial bone screw, non-bioabsorbable
  • Surgical screwdriver, reusable
  • Instrument tray, reusable
  • Dressing/utility forceps, tweezers-like, reusable

Bioplate® - M3848133640

Xpress® Compact Kit
Bioplate, Inc.
81-3364
In Commercial Distribution

  • M3848133640 ()
81-3364

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
  • Craniofacial bone screw, non-bioabsorbable
  • Surgical screwdriver, reusable
  • Instrument tray, reusable
  • Dressing/utility forceps, tweezers-like, reusable

Bioplate® - M3848133420

Compact Plus Kit ø1.9mm System
Bioplate, Inc.
81-3342
In Commercial Distribution

  • M3848133420 ()
81-3342

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
  • Craniofacial bone screw, non-bioabsorbable
  • Surgical screwdriver, reusable
  • Instrument tray, reusable
  • Dressing/utility forceps, tweezers-like, reusable

Bioplate® - M3848133400

Compact Plus Kit ø1.5mm System
Bioplate, Inc.
81-3340
In Commercial Distribution

  • M3848133400 ()
81-3340

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
  • Craniofacial bone screw, non-bioabsorbable
  • Surgical screwdriver, reusable
  • Instrument tray, reusable
  • Dressing/utility forceps, tweezers-like, reusable

Starter Kit, Straumann - D990SKST0

No Description
SMART DENTURE CONVERSIONS, LLC
SK-ST
In Commercial Distribution

  • D990SKST0 ()


  • Steel dental bur, reusable
  • Surgical screwdriver, reusable
  • Dental implant suprastructure, temporary, preformed, single-use
  • Dental implant abutment analog, laboratory
  • Dental prosthesis/implant abutment screw
  • Dental prosthesis/implant abutment screw analog, single-use

Starter Kit, Unigrip - D990SK0

No Description
SMART DENTURE CONVERSIONS, LLC
SK
In Commercial Distribution

  • D990SK0 ()


  • Steel dental bur, reusable
  • Surgical screwdriver, reusable
  • Dental implant suprastructure, temporary, preformed, single-use
  • Dental implant abutment analog, laboratory
  • Dental prosthesis/implant abutment screw
  • Dental prosthesis/implant abutment screw analog, single-use

Starter Kit, SDC BioHorizons - D990SDBHSK0

No Description
SMART DENTURE CONVERSIONS, LLC
SDBH-SK
In Commercial Distribution

  • D990SDBHSK0 ()


  • Steel dental bur, reusable
  • Surgical screwdriver, reusable
  • Dental implant suprastructure, temporary, preformed, single-use
  • Dental implant abutment analog, laboratory
  • Dental prosthesis/implant abutment screw
  • Dental prosthesis/implant abutment screw analog, single-use

Premium Starter Kit, Straumann - D990PSKST0

No Description
SMART DENTURE CONVERSIONS, LLC
PSK-ST
In Commercial Distribution

  • D990PSKST0 ()


  • Steel dental bur, reusable
  • Surgical screwdriver, reusable
  • Dental implant suprastructure, temporary, preformed, single-use
  • Dental implant abutment analog, laboratory
  • Dental prosthesis/implant abutment screw
  • Dental prosthesis/implant abutment screw analog, single-use

Leixir Starter Kit, Unigrip - D990LXDGSK0

No Description
SMART DENTURE CONVERSIONS, LLC
LXDG-SK
In Commercial Distribution

  • D990LXDGSK0 ()


  • Steel dental bur, reusable
  • Surgical screwdriver, reusable
  • Dental implant suprastructure, temporary, preformed, single-use
  • Dental implant abutment analog, laboratory
  • Dental prosthesis/implant abutment screw
  • Dental prosthesis/implant abutment screw analog, single-use
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