Yamahachi Pink CAD/CAM Disk (JUSTI)

GUDID 04582275719116

YAMAHACHI DENTAL MFG.,CO.

Dental appliance fabrication material, resin
Primary Device ID04582275719116
NIH Device Record Keyff7a3299-edcf-4349-86b1-32b1a56712b3
Commercial Distribution StatusIn Commercial Distribution
Brand NameYamahachi Pink CAD/CAM Disk (JUSTI)
Version Model Number30mm, LIGHT REDDISH PINK
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
GS104582275719116 [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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-11-10
Device Publish Date2019-08-05

On-Brand Devices [Yamahachi Pink CAD/CAM Disk (JUSTI)]

0458227571911630mm, LIGHT REDDISH PINK
0458227571910930mm, LIGHT
0458227571909330mm, DARK PINK
0458227571908630mm, ORIGINAL
0458227571907920mm, LIGHT REDDISH PINK
0458227571906220mm, LIGHT
0458227571905520mm, DARK PINK
0458227571904820mm, ORIGINAL
0458227571902425mm, LIGHT REDDISH PINK
0458227571901725mm, LIGHT
0458227571900025mm, DARK PINK
0458227571899725mm, ORIGINAL

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