JUSTI PRODUCTS OEM DISK

GUDID D080XXJSP1PCS30CLE0

YAMAHACHI DENTAL MFG.,CO.

Dental appliance fabrication material, resin
Primary Device IDD080XXJSP1PCS30CLE0
NIH Device Record Key2d0513f9-e746-47c4-8851-bd1f7188a92f
Commercial Distribution StatusIn Commercial Distribution
Brand NameJUSTI PRODUCTS OEM DISK
Version Model Number1PC,30MM,CLEAR
Company DUNS693430001
Company NameYAMAHACHI DENTAL MFG.,CO.
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD080XXJSP1PCS30CLE0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBIResin, Denture, Relining, Repairing, Rebasing

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-10
Device Publish Date2023-10-02

On-Brand Devices [JUSTI PRODUCTS OEM DISK]

D080XXJSP1PCS30ORG01PC,30MM,ORIGINAL
D080XXJSP1PCS30LRP01PC,30MM,LIGHT REDDISH PINK
D080XXJSP1PCS30LGT01PC,30MM,LIGHT
D080XXJSP1PCS30DRP01PC,30MM,DARK PINK
D080XXJSP1PCS30CLE01PC,30MM,CLEAR
D080XXJSP1PCS25ORG01PC,25MM,ORIGINAL
D080XXJSP1PCS25LRP01PC,25MM,LIGHT REDDISH PINK
D080XXJSP1PCS25LGT01PC,25MM,LIGHT
D080XXJSP1PCS25DRP01PC,25MM,DARK PINK
D080XXJSP1PCS25CLE01PC,25MM,CLEAR
D080XXJSP1PCS20ORG01PC,20MM,ORIGINAL
D080XXJSP1PCS20LRP01PC,20MM,LIGHT REDDISH PINK
D080XXJSP1PCS20LGT01PC,20MM,LIGHT
D080XXJSP1PCS20DRP01PC,20MM,DARK PINK
D080XXJSP1PCS20CLE01PC,20MM,CLEAR

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