BASIS FLOW II

GUDID D080XXBF220MLXXXXX0

YAMAHACHI DENTAL MFG.,CO.

Dental appliance fabrication material, resin
Primary Device IDD080XXBF220MLXXXXX0
NIH Device Record Keyd5b0e637-c136-44b8-9366-7e9db9c16c0d
Commercial Distribution StatusIn Commercial Distribution
Brand NameBASIS FLOW II
Version Model Number20ML
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
HIBCCD080XXBF220MLXXXXX0 [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 Date2024-05-14
Device Publish Date2024-03-28

On-Brand Devices [BASIS FLOW II]

D080XXBF2XX4LXXXXX04L
D080XXBF2X17LXXXXX017L
D080XXBF2500MXXXXX0500ML
D080XXBF2500GXXVPN0500G,V PINK
D080XXBF2500GXXOPN0500G,O PINK
D080XXBF2500GXXLFP0500G,LF PINK
D080XXBF2500GXXLFA0500G,LF α
D080XXBF2500GXXCLE0500G,CLEAR
D080XXBF26505XXVPN0650G*500ML,V PINK
D080XXBF26505XXOPN0650G*500ML,O PINK
D080XXBF26505XXLFP0650G*500ML,LF PINK
D080XXBF26505XXLFA0650G*500ML,LF α
D080XXBF26505XXCLE0650G*500ML,CLEAR
D080XXBF24020XXVPN040G*20ML,V PINK
D080XXBF24020XXOPN040G*20ML,O PINK
D080XXBF24020XXLFP040G*20ML,LF PINK
D080XXBF24020XXLFA040G*20ML,LF α
D080XXBF24020XXCLE040G*20ML,CLEAR
D080XXBF210KGXXVPN010KG,V PINK
D080XXBF210KGXXOPN010KG,O PINK
D080XXBF210KGXXLFP010KG,LF PINK
D080XXBF210KGXXLFA010KG,LF α
D080XXBF210KGXXCLE010KG,CLEAR
D080XXBF220MLXXOPN020ML
D080XXBF2040GXXVPN040G,V PINK
D080XXBF2040GXXOPN040G,O PINK
D080XXBF2040GXXLFP040G,LF PINK
D080XXBF2040GXXLFA040G,LF α
D080XXBF2040GXXCLE040G,CLEAR
D080XXBF220MLXXXXX020ML

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