Refine Bright

GUDID 04582594040588

YAMAHACHI DENTAL MFG.,CO.

Dental prosthesis restorative material, unfilled resin
Primary Device ID04582594040588
NIH Device Record Key875dc251-6061-40fd-bae7-401a3f3f5b5e
Commercial Distribution StatusIn Commercial Distribution
Brand NameRefine Bright
Version Model Number250g, MARBLE H
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 Usetrue
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
GS104582594040588 [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 Date2021-05-07
Device Publish Date2021-04-29

On-Brand Devices [Refine Bright]

04582275711738260ml
04582275711721250g, V PINK
04582275711707250g, O PINK
04582275711684250g, LF PINK
0458227571891115g*20ml, A4
0458227571890415g*20ml, A1
0458227571889810kg, O-PINK
0458227571897310kg, V PINK
0458227571896610kg, LFα
04582594040588250g, MARBLE H
04582275718980250g, A4
0458259404084715g, O PINK

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