RE-FINE BRIGHT

GUDID D080XXRFB250GXXXA30

YAMAHACHI DENTAL MFG.,CO.

Dental prosthesis restorative material, unfilled resin
Primary Device IDD080XXRFB250GXXXA30
NIH Device Record Key9b8e674c-1323-4447-ac26-fdde1239cd06
Commercial Distribution StatusIn Commercial Distribution
Brand NameRE-FINE BRIGHT
Version Model Number250G,A3
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
HIBCCD080XXRFB250GXXXA30 [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 Date2023-10-12
Device Publish Date2023-10-04

On-Brand Devices [RE-FINE BRIGHT]

0458227571160817L
D080XXRFBX15GXXOPN015G,O PINK
D080XXRFB260MXXXXX0260ML
D080XXRFB250GXXXA40250G,A4
D080XXRFB250GXXVPN0250G,V PINK
D080XXRFB250GXXOPN0250G,O PINK
D080XXRFB250GXXMBH0250G,MARBLE H
D080XXRFB250GXXLFP0250G,LF PINK
D080XXRFB15G2XXXA4015G*20ML,A4
D080XXRFB15G2XXXA1015G*20ML,A1
D080XXRFB10KGXXVPN010KG,V PINK
D080XXRFB10KGXXOPN010KG,O PINK
D080XXRFB10KGXXLFA010KG,LF α
D080XXRFBX15GXXXD4015G,D4
D080XXRFBX15GXXXD3015G,D3
D080XXRFBX15GXXXD2015G,D2
D080XXRFBX15GXXXC4015G,C4
D080XXRFBX15GXXXC3015G,C3
D080XXRFBX15GXXXC2015G,C2
D080XXRFBX15GXXXC1015G,C1
D080XXRFBX15GXXXB4015G,B4
D080XXRFBX15GXXXB3015G,B3
D080XXRFBX15GXXXB2015G,B2
D080XXRFBX15GXXXB1015G,B1
D080XXRFBX15GXXXA4015G,A4
D080XXRFBX15GXXXA3015G,A3
D080XXRFBX15GXXXA2015G,A2
D080XXRFBX15GXXXA1015G,A1
D080XXRFBX15GXXW05015G,W0.5
D080XXRFBX15GXXVPN015G,V PINK
D080XXRFBX15GXXPNK015G,PINK
D080XXRFBX15GXXMBP015G,MARBLE PINK
D080XXRFBX15GXXMBH015G,MARBLE H
D080XXRFBX15GXXLFP015G,LF PINK
D080XXRFBX15GXXLFA015G,LF α
D080XXRFBX15GXXCLP015G,CLEAR PINK
D080XXRFBX15GXXCLE015G,CLEAR
D080XXRFBX15GXXA35015G,A3.5
D080XXRFB250GXXXD40250G,D4
D080XXRFB250GXXXD30250G,D3
D080XXRFB250GXXXD20250G,D2
D080XXRFB250GXXXC40250G,C4
D080XXRFB250GXXXC30250G,C3
D080XXRFB250GXXXC20250G,C2
D080XXRFB250GXXXC10250G,C1
D080XXRFB250GXXXB40250G,B4
D080XXRFB250GXXXB30250G,B3
D080XXRFB250GXXXB20250G,B2
D080XXRFB250GXXXB10250G,B1
D080XXRFB250GXXXA30250G,A3

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