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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 ClearCorrect device is fabricated of clear thin thermoformed polyeurethane plastic in a sequential series to progressively reposition teeth. Corrective force to straighten teeth is delivered via minor changes into a position in each subsequent aligner.
Clearcorrect Operating, LLC
Aligner (Single-Layer)
Not in Commercial Distribution

  • D865REF00011 ()
REF-01

  • Orthodontic progressive aligner
The ClearCorrect device is fabricated of clear thin thermoformed polyeurethane plastic in a sequential series to progressively reposition teeth. Corrective force to straighten teeth is delivered via minor changes into a position in each subsequent aligner.
Clearcorrect Operating, LLC
MFG-0100 5.0
Not in Commercial Distribution

  • D865REF0001 ()
REF-01

  • Orthodontic progressive aligner
STELLAR CHROME is a dual cure acrylic that light cures in 20 seconds and self cures in 120 seconds. Used for All-on-X pick-up and conversions, locator pick-up, create Implant Verification Jigs, Implant Abutment Seating Guide, Indexes.
Taub Products
Pink Resin - 1ea 5.85 gm Syr Bulk
In Commercial Distribution

  • D8375011100 ()

  • Weight: 5.85 Gram
50-1110

  • Dental acrylic resin
STELLAR CHROME is a dual cure acrylic that light cures in 20 seconds and self cures in 120 seconds. Used for All-on-X pick-up and conversions, locator pick-up, create Implant Verification Jigs, Implant Abutment Seating Guide, Indexes.
Taub Products
Pink Resin - 1ea 5.85 gm Syr
In Commercial Distribution

  • D8375011000 ()

  • Weight: 5.85 Gram
50-1100

  • Dental acrylic resin
A digital vision testing system intended as an aid in assessment of visual function in patients. The software delivers algorithms that utilize a visual display which may be a tablet, smart phone, a computer screen, etc.
AMA Optics, Inc.
DiagnosticGame
In Commercial Distribution

  • G506DG010 ()
DG01

  • Vision self-testing software
Qty 2 - 0.5mm x 0.5cm Platinum VISICOILS With a 10mm spacer in 21g x 20cm Needle 2 - 0.50mm x 0.5cm VISICOIL MR separated by a 10mm spacer (Non-Stranded) loaded in an 21 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
PTTL-050-11021
In Commercial Distribution

  • B887PTTL050110210 ()
PTTL-050-11021

  • Radiological image marker, implantable
Qty2-1.10mmx0.5cm Gold VISICOILS 15mm Spacer 17g x 20cm Needle Stranded 2 - 1.10mm x 0.50cm VISICOIL separated by a 15mm PGLA spacer (Stranded with PGLA Sleeve) loaded in an 17 gauge pre-waxed brachytherapy needle 20cm in length.
Izi Medical Products, LLC
TLS-110-31517
In Commercial Distribution

  • B887TLS110315170 ()
TLS-110-31517

  • Radiological image marker, implantable
Qty2-0.75mmx0.5cm Gold VISICOILS 15mm Spacer 18g x 20cm Needle Stranded 2 - 0.75mm x 0.50cm VISICOIL separated by a 15mm PGLA Spacer (Stranded with PGLA Sleeve) loaded in an 18 gauge pre-waxed brachytherapy needle 20cm in length.
Izi Medical Products, LLC
TLS-075-31518
In Commercial Distribution

  • B887TLS075315180 ()
TLS-075-31518

  • Radiological image marker, implantable
Qty 2 - 1.10mm x 0.5cm Gold VISICOILS 20mm Spacer 17g x 20cm Needle 2 - 1.10mm x 0.50cm VISICOIL separated by a 20mm PGLA spacer (Non-Stranded) loaded in an 17 gauge pre-waxed brachytherapy needle 20cm in length.
Izi Medical Products, LLC
TL-110-62017
In Commercial Distribution

  • B887TL110620170 ()
TL-110-62017

  • Radiological image marker, implantable
Qty 2 - 1.10mm x 0.5cm Gold VISICOILS 15mm Spacer 17g x 20cm Needle 2 - 1.10mm x 0.50cm VISICOIL separated by a 15mm PGLA spacer (Non-Stranded) loaded in an 17 gauge pre-waxed brachytherapy needle 20cm in length.
Izi Medical Products, LLC
TL-110-21517
In Commercial Distribution

  • B887TL110215170 ()
TL-110-21517

  • Radiological image marker, implantable
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