BASIS

GUDID D080XXBSSX40GXXD100

YAMAHACHI DENTAL MFG.,CO.

Dental appliance fabrication material, resin

• Primary Device ID: D080XXBSSX40GXXD100
• NIH Device Record Key: df3291d5-65ca-4a8d-b00d-972bbbf14688
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BASIS
• Version Model Number: 40G,D-10
• 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	D080XXBSSX40GXXD100 [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: 2023-10-09
• Device Publish Date: 2023-09-29

On-Brand Devices [BASIS]

• 04582275718485: 500ml
• 04582275711141: 1kg, V PINK
• 04582275710717: 3kg, O PINK
• 04582275710694: 1kg, O PINK
• 04582275719253: 10kg, V PINK
• D080XXBSSX3KGXXOPN0: 3KG,O PINK
• D080XXBSSX1KGXXVPN0: 1KG,V PINK
• D080XXBSSX1KGXXOPN0: 1KG,O PINK
• D080XXBSS10KGXXVPN0: 10KG,V PINK
• D080XXBSS500MXXXXX0: 500ML
• D080XXBSSXX1LXXXXX0: 1L
• D080XXBSSX40GXXVPN0: 40G,V PINK
• D080XXBSSX40GXXRPN0: 40G,R PINK
• D080XXBSSX40GXXPNK0: 40G,PINK
• D080XXBSSX40GXXOPN0: 40G,O PINK
• D080XXBSSX40GXXLGP0: 40G,LIGHT PINK
• D080XXBSSX40GXXLFW0: 40G,LF W
• D080XXBSSX40GXXLFP0: 40G,LF PINK
• D080XXBSSX40GXXLFA0: 40G,LF α
• D080XXBSSX40GXXDTP0: 40G,D-T PINK
• D080XXBSSX40GXXDRP0: 40G,DARK PINK
• D080XXBSSX40GXXDLP0: 40G,D-LF PINK
• D080XXBSSX40GXXDLA0: 40G,D-LF α
• D080XXBSSX40GXXD100: 40G,D-10
• D080XXBSSX40GXXCLE0: 40G,CLEAR
• D080XXBSSX3KGXXVPN0: 3KG,V PINK
• D080XXBSSX3KGXXRPN0: 3KG,R PINK
• D080XXBSSX3KGXXPNK0: 3KG,PINK
• D080XXBSSX3KGXXLGP0: 3KG,LIGHT PINK
• D080XXBSSX3KGXXLFW0: 3KG,LF W
• D080XXBSSX3KGXXLFP0: 3KG,LF PINK
• D080XXBSSX3KGXXLFA0: 3KG,LF α
• D080XXBSSX3KGXXDTP0: 3KG,D-T PINK
• D080XXBSSX3KGXXDRP0: 3KG,DARK PINK
• D080XXBSSX3KGXXDLP0: 3KG,D-LF PINK
• D080XXBSSX3KGXXDLA0: 3KG,D-LF α
• D080XXBSSX3KGXXD100: 3KG,D-10
• D080XXBSSX3KGXXCLE0: 3KG,CLEAR
• D080XXBSSX1KGXXRPN0: 1KG,R PINK
• D080XXBSSX1KGXXPNK0: 1KG,PINK
• D080XXBSSX1KGXXLGP0: 1KG,LIGHT PINK
• D080XXBSSX1KGXXLFW0: 1KG,LF W
• D080XXBSSX1KGXXLFP0: 1KG,LF PINK
• D080XXBSSX1KGXXLFA0: 1KG,LF α
• D080XXBSSX1KGXXDTP0: 1KG,D-T PINK
• D080XXBSSX1KGXXDRP0: 1KG,DARK PINK
• D080XXBSSX1KGXXDLP0: 1KG,D-LF PINK
• D080XXBSSX1KGXXDLA0: 1KG,D-LF α
• D080XXBSSX1KGXXD100: 1KG,D-10
• D080XXBSSX1KGXXCLE0: 1KG,CLEAR