BASIS HI

GUDID D080XXBHIX1KGXXLFA0

YAMAHACHI DENTAL MFG.,CO.

Dental appliance fabrication material, resin

• Primary Device ID: D080XXBHIX1KGXXLFA0
• NIH Device Record Key: 47f2d9d6-9854-46c0-8367-03796e2e7365
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BASIS HI
• Version Model Number: 1KG,LF α
• 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	D080XXBHIX1KGXXLFA0 [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: 2023-10-10
• Device Publish Date: 2023-10-02

On-Brand Devices [BASIS HI]

• 04582275710472: 1kg, V PINK
• 04582275710410: 3kg, O PINK
• 04582275710403: 40g, O PINK
• 04582275710397: 1kg, O PINK
• 04582594041394: 1kg, V PINK
• 04582594041387: 40g*25ml, LF α
• 04582594041370: 40g, LF α
• 04582594041363: 40g, LF PINK
• 04582594041356: 10kg, LF PINK
• D080XXBHIX40GXXOPN0: 40G,O PINK
• D080XXBHIX40GXXLFP0: 40G,LF PINK
• D080XXBHIX40GXXLFA0: 40G,LF α
• D080XXBHIX3KGXXOPN0: 3KG,O PINK
• D080XXBHIX1KGXXVPN0: 1KG,V PINK
• D080XXBHIX1KGXXOPN0: 1KG,O PINK
• D080XXBHI10KGXXLFP0: 10KG,LF PINK
• D080XXBHIX40GXXVPN0: 40G,V PINK
• D080XXBHIX3KGXXVPN0: 3KG,V PINK
• D080XXBHIX3KGXXLFP0: 3KG,LF PINK
• D080XXBHIX3KGXXLFA0: 3KG,LF α
• D080XXBHIX1KGXXLFP0: 1KG,LF PINK
• D080XXBHIX1KGXXLFA0: 1KG,LF α
• D080XXBHI4020XXVPN0: 40G*20ML,V PINK
• D080XXBHI4020XXOPN0: 40G*20ML,O PINK
• D080XXBHI4020XXLFP0: 40G*20ML,LF PINK
• D080XXBHI4020XXLFA0: 40G*20ML,LF α
• D080XXBHI10KGXXVPN0: 10KG,V PINK
• D080XXBHI10KGXXOPN0: 10KG,O PINK
• D080XXBHI10KGXXLFA0: 10KG,LF α
• D080XXBHI100GXXVPN0: 100G,V PINK
• D080XXBHI100GXXOPN0: 100G,O PINK
• D080XXBHI100GXXLFP0: 100G,LF PINK
• D080XXBHI100GXXLFA0: 100G,LF α