BASIS TWIN CURE

GUDID D080XXBTC20MLXXXXX0

YAMAHACHI DENTAL MFG.,CO.

Dental appliance fabrication material, resin
Primary Device IDD080XXBTC20MLXXXXX0
NIH Device Record Key52a2bba5-7336-42e7-a2c0-b6d0d56cd72a
Commercial Distribution StatusIn Commercial Distribution
Brand NameBASIS TWIN CURE
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
HIBCCD080XXBTC20MLXXXXX0 [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 Date2023-10-10
Device Publish Date2023-10-02

On-Brand Devices [BASIS TWIN CURE]

045822757111271kg, V PINK
045822757110661kg, O PINK
045822757110351kg, LF PINK
04582275711028500ml
0458259404083040g, O PINK
D080XXBTCX40GXXOPN040G,O PINK
D080XXBTCX1KGXXVPN01KG,V PINK
D080XXBTCX1KGXXOPN01KG,O PINK
D080XXBTCX1KGXXLFP01KG,LF PINK
D080XXBTC500MXXXXX0500ML
D080XXBTCX40GXXVPN040G,V PINK
D080XXBTCX40GXXLFP040G,LF PINK
D080XXBTCX40GXXLFA040G,LF α
D080XXBTCX1KGXXLFA01KG,LF α
D080XXBTCX17LXXXXX017L
D080XXBTC4020XXVPN040G*20ML,V PINK
D080XXBTC4020XXOPN040G*20ML,O PINK
D080XXBTC4020XXLFP040G*20ML,LF PINK
D080XXBTC4020XXLFA040G*20ML,LF α
D080XXBTC20MLXXXXX020ML

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.