REFINE BRIGHT

GUDID 04582275711707

YAMAHACHI DENTAL MFG.,CO.

Dental appliance fabrication material, cured
Primary Device ID04582275711707
NIH Device Record Key6f580d9d-0b6a-4098-b48b-a35c1e9eaeaa
Commercial Distribution StatusIn Commercial Distribution
Brand NameREFINE BRIGHT
Version Model Number250g, O 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
GS104582275711707 [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 Number3
Public Version Date2018-07-06
Device Publish Date2018-04-06

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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