Refine Bright

GUDID 04582275718973

YAMAHACHI DENTAL MFG.,CO.

Dental prosthesis restorative material, unfilled resin
Primary Device ID04582275718973
NIH Device Record Key67538b98-6f87-4988-84fc-7d9a1f57b397
Commercial Distribution StatusIn Commercial Distribution
Brand NameRefine Bright
Version Model Number10kg, V 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 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
GS104582275718973 [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 Date2019-07-17
Device Publish Date2019-07-09

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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