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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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VISTADENT® OC - D7462731199L1

VISTADENT® OC COMPLETE LATIN AMERICA
DENTSPLY SIRONA ORTHODONTICS INC.
27-311-99L
Not in Commercial Distribution

  • D7462731199L1 ()
27-311-99L

  • CAD/CAM software

VISTADENT® OC - D7462731099U1

VISTADENT® OC COMPLETE UPDATE
DENTSPLY SIRONA ORTHODONTICS INC.
27-310-99U
Not in Commercial Distribution

  • D7462731099U1 ()
27-310-99U

  • CAD/CAM software

VISTADENT® OC - D7462731070U1

VISTADENT® OC CONSULTANT UPDATE
DENTSPLY SIRONA ORTHODONTICS INC.
27-310-70U
Not in Commercial Distribution

  • D7462731070U1 ()
27-310-70U

  • CAD/CAM software

Glidewell Restorative CT - D745701152CTS00010

Glidewell Restorative CT Scanner
Prismatik Dentalcraft, Inc
70-1152-CTS0001
In Commercial Distribution

  • D745701152CTS00010 ()
70-1152-CTS0001

  • CAD/CAM software

fastdesign.io - D745701181MIL00160

fastmill.io system (fastdesign.io computer + fastmill.io)
Prismatik Dentalcraft, Inc
70-1181-MIL0016
In Commercial Distribution

  • D745701181MIL00160 ()
70-1181-MIL0016

  • CAD/CAM software

ANDI - 00754016387111

No Description
Imeka Solutions Inc
1
In Commercial Distribution

  • 00754016387111 ()


  • Radiological PACS software

reSET-O® Non-Monetary CM - 10196439000036

reSET-O is intended to increase retention of patients with Opioid Use Disorder (OUD) in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management, for patients 18 years or older who are currently under the supervision of a clinician. reSET-O is indicated as a prescription-only digital therapeutic. This configuration of reSET-O is intended to provide virtual incentives to patients based on the Contingency management system.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution

  • 10196439000036 ()
N/A

  • Psychological assessment software

reSET-O® - 10196439000029

reSET-O is intended to increase retention of patients with Opioid Use Disorder (OUD) in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management, for patients 18 years or older who are currently under the supervision of a clinician. reSET-O is indicated as a prescription-only digital therapeutic. This configuration of reSET-O is intended to provide virtual incentives as well as monetary incentives to the patients based on the Contingency management system.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution

  • 10196439000029 ()
N/A

  • Psychological assessment software

reSET® Non-Monetary CM - 10196439000012

reSET is intended to provide cognitive behavioral therapy, as an adjunct to a contingency management system, for patients 18 years of age and older who are currently enrolled in outpatient treatment under the supervision of a clinician. reSET is indicated as a 12-week (90 days) prescriptiononly treatment for patients with Substance Use Disorder (SUD), who are not currently on opioid replacement therapy, who do not abuse alcohol solely, or who do not abuse opioids as their primary substance of abuse. It is intended to: increase abstinence from a patient’s substances of abuse during treatment, and increase retention in the outpatient treatment program This configuration of reSET is intended to provide virtual incentives to patients based on the Contingency management system.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution

  • 10196439000012 ()
N/A

  • Psychological assessment software

reSET® - 10196439000005

reSET is intended to provide cognitive behavioral therapy, as an adjunct to a contingency management system, for patients 18 years of age and older who are currently enrolled in outpatient treatment under the supervision of a clinician. reSET is indicated as a 12-week (90 days) prescriptiononly treatment for patients with Substance Use Disorder (SUD), who are not currently on opioid replacement therapy, who do not abuse alcohol solely, or who do not abuse opioids as their primary substance of abuse. It is intended to: increase abstinence from a patient’s substances of abuse during treatment, and increase retention in the outpatient treatment program. This configuration of reSET is intended to provide virtual incentives as well as monetary incentives to the patients based on the Contingency management system.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution

  • 10196439000005 ()
N/A

  • Psychological assessment software
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