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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 Gel Etch Dental Conditioner - D801SP70128B1

Gel Etch is a High Viscosity Enamel Etching Agent for All Bonding Purposes. 60 gram Green Gel Etch with 1 cc Applicator Syringe. Boxed.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 70-125 B
In Commercial Distribution

  • D801SP70128B1 ()
70-128

  • Dental etching solution

HUMA - G2871002

The Huma platform is a modular Software as a Medical Device (SaMD) which may utilise compatible devices and software to obtain data collated via a mobile app or web app and delivered to the clinician via a web portal or web app where it may be viewed to drive clinical management. It is intended to be used for the physiological and non-physiological intermittent or spot-check monitoring of all condition patients in professional healthcare facilities, such as clinics, hospitals or skilled nursing facilities, or in the patient’s home setting. It is intended for the monitoring of patients by trained healthcare professionals. The Huma platform comprises a number of different modules and functionalities that can be selected by the customer for configuration of care plans which can be further personalised for the patients. Clinical information collected from these modules is displayed on a clinician web portal and patient app with the addition of flagging out of range datasets, trend visualisation, goal setting and communication channels between clinicians and patients.
MedoPad Inc.
1.34
In Commercial Distribution

  • G2871002 ()
1002

  • Self-care monitoring/reporting software

TPH®3 Micro Matrix Restorative - D0026427061

TPH®3 Easy-Twist Syringe Introductory Kit
DENTSPLY INTERNATIONAL INC.
642706
Not in Commercial Distribution

  • D0026427061 ()

  • Weight: 3 Gram
  • Total Volume: 3 Milliliter
  • 8 TPH3 Syringes, 5 P&B Unit Doses, 1 Prisma Gloss Fine and Extrafine Syringe, 1 syringe Tooth Cond Gel, 1 shade guide, 25 polishing cups, 1 mandrel, Enhance Discs, Cups, & Points, 5 App Tips
642706

  • Dental composite resin

Esthet-X® HD High Definition Micro Matrix Restorative - D0026306071

Esthet-X® HD High Definition Micro Matrix Restorative Total-Etch Direct Restorative Kit
DENTSPLY INTERNATIONAL INC.
630607
Not in Commercial Distribution

  • D0026306071 ()

  • Weight: 0.25 Gram
  • 6 Compules® Tips, 1 Compules® Tips Gun, 3 Compula® Tips, Enhance® Finishers, 6 Bond Unit Doses, 1 Unit Dose Holder, 6 Flocked Applicator Tips, 1 Syringe Tooth Cond Gel, 25 App Tips
  • Total Volume: 3 Milliliter
630607

  • Dental composite resin

FluoroCore® 2+ Dual Cure Core Build-Up Material + Fast Endodontic Post Cement - D0026124001

FluoroCore® 2+ Dual Cure Core Build-Up Material + Fast Endodontic Post Cement Introductory Kit
DENTSPLY INTERNATIONAL INC.
612400
Not in Commercial Distribution

  • D0026124001 ()

  • Weight: 4.75 Gram
  • 2 Tooth Colored Syringes, 2 Blue Syringes, 1 bottle each Xeno®, P&B, and activator, 25 Mixing Tips, 25 Intraoral Tips, 10 Endo Intaoral Tips, 1 Disp Well, 50 App Tips, 50 Root Canal Tips
612400

  • Dental composite resin

OsteoSurge 300 Putty - 10889981055844

OsteoSurge300 Putty,5 cc - demineralized human bone mixed with poloxamer resorbable reverse phase medium. OsteoSurge300 is formulated into a putty form and is provided in a sterile, single use package.
ISOTIS ORTHOBIOLOGICS, INC.
56500050
In Commercial Distribution

  • M386565000501 ()
  • 10889981055844 ()

  • 5cc
56500050

  • Bone matrix implant, human-derived

Light Bond - D798LBFSF0

Light Bond™ sealants are intended for use as a light cure sealant resin for bonding under an orthodontic adhesive. This is the 3 cc Filled Sealant Resin with Fluoride.
RELIANCE ORTHODONTIC PRODUCTS INC
LBFSF
In Commercial Distribution

  • D798LBFSF0 ()
LBFSF

  • Dental composite resin

ER920 Rozinn - B146ER9R0

ENHANCED ALGORITHM ECG EVENT RECORDER
BRAEMAR MANUFACTURING, LLC
900-0557-06
In Commercial Distribution

  • B146ER9R0 ()
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&

  • Electrocardiography telemetric monitoring system

Accell Evo3 Putty - 10889981055400

Accell Evo3 Putty,5 cc - demineralized human bone mixed with poloxamer resorbable reverse phase medium. Accell Evo3 is formulated into a putty form and is provided in a sterile, single use package.
ISOTIS ORTHOBIOLOGICS, INC.
02-5000-050
In Commercial Distribution

  • M3860250000501 ()
  • 10889981055400 ()

  • 5cc
02-5000-050

  • Bone matrix implant, human-derived

Plastic Conditioner - D798PL0

The Reliance Plastic Appliance Conditioner is intended for use as a conditioner of plastic brackets or acrylic appliances in preparation for bonding with any adhesive, sealant or cement. It can also be used to condition a composite restoration or acrylic jacket prior to bonding and to rebond a bracket impregnated with adhesive. 10 cc bottle
RELIANCE ORTHODONTIC PRODUCTS INC
PL
In Commercial Distribution

  • D798PL0 ()
PL

  • Dentine bonding agent/set
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