BASIS FLOW II

GUDID D080XXBF2040GXXLFP0

YAMAHACHI DENTAL MFG.,CO.

Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin

• Primary Device ID: D080XXBF2040GXXLFP0
• NIH Device Record Key: e7d892c0-8a77-416e-9aab-a25b6521c499
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BASIS FLOW II
• Version Model Number: 40G,LF PINK
• Company DUNS: 693430001
• Company Name: YAMAHACHI DENTAL MFG.,CO.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D080XXBF2040GXXLFP0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233859

FDA Product Code

• EBI: Resin, Denture, Relining, Repairing, Rebasing

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-05
• Device Publish Date: 2024-03-28

On-Brand Devices [BASIS FLOW II]

• D080XXBF2XX4LXXXXX0: 4L
• D080XXBF2X17LXXXXX0: 17L
• D080XXBF2500MXXXXX0: 500ML
• D080XXBF2500GXXVPN0: 500G,V PINK
• D080XXBF2500GXXOPN0: 500G,O PINK
• D080XXBF2500GXXLFP0: 500G,LF PINK
• D080XXBF2500GXXLFA0: 500G,LF α
• D080XXBF2500GXXCLE0: 500G,CLEAR
• D080XXBF26505XXVPN0: 650G*500ML,V PINK
• D080XXBF26505XXOPN0: 650G*500ML,O PINK
• D080XXBF26505XXLFP0: 650G*500ML,LF PINK
• D080XXBF26505XXLFA0: 650G*500ML,LF α
• D080XXBF26505XXCLE0: 650G*500ML,CLEAR
• D080XXBF24020XXVPN0: 40G*20ML,V PINK
• D080XXBF24020XXOPN0: 40G*20ML,O PINK
• D080XXBF24020XXLFP0: 40G*20ML,LF PINK
• D080XXBF24020XXLFA0: 40G*20ML,LF α
• D080XXBF24020XXCLE0: 40G*20ML,CLEAR
• D080XXBF210KGXXVPN0: 10KG,V PINK
• D080XXBF210KGXXOPN0: 10KG,O PINK
• D080XXBF210KGXXLFP0: 10KG,LF PINK
• D080XXBF210KGXXLFA0: 10KG,LF α
• D080XXBF210KGXXCLE0: 10KG,CLEAR
• D080XXBF220MLXXOPN0: 20ML
• D080XXBF2040GXXVPN0: 40G,V PINK
• D080XXBF2040GXXOPN0: 40G,O PINK
• D080XXBF2040GXXLFP0: 40G,LF PINK
• D080XXBF2040GXXLFA0: 40G,LF α
• D080XXBF2040GXXCLE0: 40G,CLEAR