Yamahachi Pink CAD/CAM Disk (JUSTI)

GUDID 04582275719055

YAMAHACHI DENTAL MFG.,CO.

Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin

• Primary Device ID: 04582275719055
• NIH Device Record Key: e12ef22b-e874-47e0-a1c8-3a13e5193954
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Yamahachi Pink CAD/CAM Disk (JUSTI)
• Version Model Number: 20mm, DARK PINK
• 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	04582275719055 [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