BASIS FLOW II

GUDID D080XXBF24020XXCLE0

YAMAHACHI DENTAL MFG.,CO.

Dental appliance fabrication material, resin

• Primary Device ID: D080XXBF24020XXCLE0
• NIH Device Record Key: 632c69fb-2e54-4c3e-9082-a835aed53841
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BASIS FLOW II
• Version Model Number: 40G*20ML,CLEAR
• 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	D080XXBF24020XXCLE0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131036
• 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: 2023-10-10
• Device Publish Date: 2023-10-02

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
• D080XXBF220MLXXXXX0: 20ML