FRESH Bold Impression Material 1-7486

GUDID 00815619020536

EXACTA DENTAL PRODUCTS INC

Silicone dental impression material
Primary Device ID00815619020536
NIH Device Record Key3f175acb-76fb-43b9-9692-56201fd40e92
Commercial Distribution StatusIn Commercial Distribution
Brand NameFRESH Bold Impression Material
Version Model NumberMonophase Cartridge
Catalog Number1-7486
Company DUNS016325552
Company NameEXACTA DENTAL PRODUCTS INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100815619020536 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELWMaterial, Impression

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

On-Brand Devices [FRESH Bold Impression Material]

00815619021403FRESH Bold Impression Material Light Body Bulk
00815619021397FRESH Bold Impression Material Light Body Fast Set
00815619021380FRESH Bold Impression Material Monophase Fast Set
00815619021373FRESH Bold Impression Material Monophase Fast Set
00815619021366FRESH Bold Impression Material Liquid Putty Bulk
00815619021359FRESH Bold Impression Material Liquid Putty
00815619021342FRESH Bold Impression Material Clear Bite Bulk
00815619021335FRESH Bold Impression Material Clear Bite
00815619021328FRESH Bold Impression Material Heavy Body Fast Set Bulk
00815619021311FRESH Bold Impression Material Heavy Body Fast Set
00815619021304FRESH Bold Impression Material Medium Body Fast Set Bulk
00815619021298FRESH Bold Impression Material Medium Body Fast Set
00815619021274FRESH Bold Impression Material Monophase Bulk
00815619021267FRESH Bold Impression Material Monophase
00815619021137FRESH Bold Impression Material Bite Registration Bulk
00815619021120FRESH Bold Impression Material Bite Registration
00815619020888FRESH Bold Impression Material Putty
00815619020871FRESH Bold Impression Material Heavy Body Mega Pack
00815619020628FRESH Bold Impression Material Blu Max Bite Registration Cartridge
00815619020604FRESH Bold Impression Material Light Body Fast Set Cartridge
00815619020598FRESH Bold Impression Material Monophase Fast Set Cartridge
00815619020581FRESH Bold Impression Material Clear Liquid Putty Cartridge
00815619020574FRESH Bold Impression Material Clear Bite Cartridge
00815619020567FRESH Bold Impression Material Heavy Body Cartridge
00815619020550FRESH Bold Impression Material Medium Body Cartridge
00815619020536Monophase Cartridge
00815619020420FRESH Bold Impression Material Bite Registration Cartridge

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