Yamahachi Pink CAD/CAM Disk (JUSTI)

GUDID 04582275719086

YAMAHACHI DENTAL MFG.,CO.

Dental appliance fabrication material, resin

• Primary Device ID: 04582275719086
• NIH Device Record Key: 454dd946-db19-4fd9-978d-ffc5acb9345e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Yamahachi Pink CAD/CAM Disk (JUSTI)
• Version Model Number: 30mm, ORIGINAL
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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
GS1	04582275719086 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172683

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-11-10
• Device Publish Date: 2019-08-05

On-Brand Devices [Yamahachi Pink CAD/CAM Disk (JUSTI)]

• 04582275719116: 30mm, LIGHT REDDISH PINK
• 04582275719109: 30mm, LIGHT
• 04582275719093: 30mm, DARK PINK
• 04582275719086: 30mm, ORIGINAL
• 04582275719079: 20mm, LIGHT REDDISH PINK
• 04582275719062: 20mm, LIGHT
• 04582275719055: 20mm, DARK PINK
• 04582275719048: 20mm, ORIGINAL
• 04582275719024: 25mm, LIGHT REDDISH PINK
• 04582275719017: 25mm, LIGHT
• 04582275719000: 25mm, DARK PINK
• 04582275718997: 25mm, ORIGINAL