RE-FINE BRIGHT

GUDID D080XXRFBX15GXXA350

YAMAHACHI DENTAL MFG.,CO.

Dental appliance fabrication material, resin

• Primary Device ID: D080XXRFBX15GXXA350
• NIH Device Record Key: c246dd5b-de12-4903-9167-f01b2b5d8482
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RE-FINE BRIGHT
• Version Model Number: 15G,A3.5
• 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	D080XXRFBX15GXXA350 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131036

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: 2023-10-12
• Device Publish Date: 2023-10-04

On-Brand Devices [RE-FINE BRIGHT]

• 04582275711608: 17L
• D080XXRFBX15GXXOPN0: 15G,O PINK
• D080XXRFB260MXXXXX0: 260ML
• D080XXRFB250GXXXA40: 250G,A4
• D080XXRFB250GXXVPN0: 250G,V PINK
• D080XXRFB250GXXOPN0: 250G,O PINK
• D080XXRFB250GXXMBH0: 250G,MARBLE H
• D080XXRFB250GXXLFP0: 250G,LF PINK
• D080XXRFB15G2XXXA40: 15G*20ML,A4
• D080XXRFB15G2XXXA10: 15G*20ML,A1
• D080XXRFB10KGXXVPN0: 10KG,V PINK
• D080XXRFB10KGXXOPN0: 10KG,O PINK
• D080XXRFB10KGXXLFA0: 10KG,LF α
• D080XXRFBX15GXXXD40: 15G,D4
• D080XXRFBX15GXXXD30: 15G,D3
• D080XXRFBX15GXXXD20: 15G,D2
• D080XXRFBX15GXXXC40: 15G,C4
• D080XXRFBX15GXXXC30: 15G,C3
• D080XXRFBX15GXXXC20: 15G,C2
• D080XXRFBX15GXXXC10: 15G,C1
• D080XXRFBX15GXXXB40: 15G,B4
• D080XXRFBX15GXXXB30: 15G,B3
• D080XXRFBX15GXXXB20: 15G,B2
• D080XXRFBX15GXXXB10: 15G,B1
• D080XXRFBX15GXXXA40: 15G,A4
• D080XXRFBX15GXXXA30: 15G,A3
• D080XXRFBX15GXXXA20: 15G,A2
• D080XXRFBX15GXXXA10: 15G,A1
• D080XXRFBX15GXXW050: 15G,W0.5
• D080XXRFBX15GXXVPN0: 15G,V PINK
• D080XXRFBX15GXXPNK0: 15G,PINK
• D080XXRFBX15GXXMBP0: 15G,MARBLE PINK
• D080XXRFBX15GXXMBH0: 15G,MARBLE H
• D080XXRFBX15GXXLFP0: 15G,LF PINK
• D080XXRFBX15GXXLFA0: 15G,LF α
• D080XXRFBX15GXXCLP0: 15G,CLEAR PINK
• D080XXRFBX15GXXCLE0: 15G,CLEAR
• D080XXRFBX15GXXA350: 15G,A3.5
• D080XXRFB250GXXXD40: 250G,D4
• D080XXRFB250GXXXD30: 250G,D3
• D080XXRFB250GXXXD20: 250G,D2
• D080XXRFB250GXXXC40: 250G,C4
• D080XXRFB250GXXXC30: 250G,C3
• D080XXRFB250GXXXC20: 250G,C2
• D080XXRFB250GXXXC10: 250G,C1
• D080XXRFB250GXXXB40: 250G,B4
• D080XXRFB250GXXXB30: 250G,B3
• D080XXRFB250GXXXB20: 250G,B2
• D080XXRFB250GXXXB10: 250G,B1
• D080XXRFB250GXXXA30: 250G,A3