YAMAHACHI PINK CAD/CAM DISK

GUDID 04582275719796

YAMAHACHI DENTAL MFG.,CO.

Dental appliance fabrication material, cured

• Primary Device ID: 04582275719796
• NIH Device Record Key: b5a685b8-91e0-4a48-a264-bce03d01abda
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: YAMAHACHI PINK CAD/CAM DISK
• Version Model Number: 98.5mm*30mm, V 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	04582275719796 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-19
• Device Publish Date: 2021-04-10

On-Brand Devices [YAMAHACHI PINK CAD/CAM DISK]

• 04582275719932: 98.5mm*35mm, C2+V PINK
• 04582275719925: 98.5mm*35mm, B2+V PINK
• 04582275719918: 98.5mm*35mm, A3.5+V PINK
• 04582275719901: 98.5mm*35mm, A3+V PINK
• 04582275719895: 98.5mm*35mm, A2+V PINK
• 04582275719888: 98.5mm*35mm, A1+V PINK
• 04582275719840: 98.5mm*35mm, V PINK
• 04582275719796: 98.5mm*30mm, V PINK
• 04582275719727: 95mm*20mm, V PINK