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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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SciPharm Cure-On Touch Orthodontic Adhesive - D801SP65022B1

Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Part B. Boxed.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-022 B
In Commercial Distribution

  • D801SP65022B1 ()
65-022

  • Dentine adhesive

SciPharm Cure-On Touch Orthodontic Adhesive - D801SP650221

Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Part B. Boxed.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-022
In Commercial Distribution

  • D801SP650221 ()
65-022

  • Dentine adhesive

Lucitone® 199 - D0019884980

Dark Pink. This is sold as part of the 11-Unit Package (688403) only. It is not sold separately.
Dentsply International Inc.
Denture Base Powder
In Commercial Distribution

  • D0019884980 ()

  • Weight: 231 Gram


  • Dental appliance fabrication material, resin

Lucitone® 199 - D0019880980

Original Shade. This is sold as part of the 11-Unit Package (688103) only. It is not sold separately.
Dentsply International Inc.
Denture Base Powder
In Commercial Distribution

  • D0019880980 ()

  • Weight: 231 Gram


  • Dental appliance fabrication material, resin

Hy-Pro Lucitone® - D0019843070

Pink. This is part of the Hy-Pro Lucitone 11-Unit Package Pink (684302) only. It is not sold separately.
Dentsply International Inc.
Denture Base Powder
Not in Commercial Distribution

  • D0019843070 ()

  • Weight: 231 Gram


  • Dental appliance fabrication material, resin

Hy-Pro Lucitone® - D0019841030

Fibered. This is part of the Hy-Pro Lucitone 11-Unit Package Fibered (684101) only. It is not sold separately.
Dentsply International Inc.
Denture Base Powder
Not in Commercial Distribution

  • D0019841030 ()

  • Weight: 231 Gram


  • Dental appliance fabrication material, resin

DENTSPLY® Repair Material - D0019800560

This is sold as part of the Dentsply Repair Material Starter Pack 680050. It is not sold seperately.
Dentsply International Inc.
Liquid
Not in Commercial Distribution

  • D0019800560 ()

  • Total Volume: 58 Milliliter


  • Dental appliance fabrication material, resin

Earlens Fitting Software, USB - 00850013007295

Inductive Earlens Fitting Software. Lot Number is for manufacturing packaging of software. Version is in Application Identifier (8012).
EARLENS CORPORATION
ELF002
Not in Commercial Distribution

  • 00850013007295 ()
ELF002

  • Audiometric/hearing device software

A-1-Antichymotrypsin RPab - B502BSB50050

A-1-Antichymotrypsin is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in bufferpH 7.5
BIO SB, INC.
Concentrate, 0.5 ml
In Commercial Distribution

  • B502BSB50050 ()
BSB 5005

  • Alpha-1-antichymotrypsin IVD, antibody

Tinto A-1-Antichymotrypsin RPab - B502BSB50010

A-1-Antichymotrypsin is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in bufferpH 7.5,
BIO SB, INC.
Predilute, 3 ml
In Commercial Distribution

  • B502BSB50010 ()
BSB5001

  • Alpha-1-antichymotrypsin IVD, antibody
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