REFINE BRIGHT

GUDID 04582275711707

YAMAHACHI DENTAL MFG.,CO.

Dental appliance fabrication material, cured

• Primary Device ID: 04582275711707
• NIH Device Record Key: 6f580d9d-0b6a-4098-b48b-a35c1e9eaeaa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REFINE BRIGHT
• Version Model Number: 250g, O 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: 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
GS1	04582275711707 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-06

On-Brand Devices [REFINE BRIGHT]

• 04582275711738: 260ml
• 04582275711721: 250g, V PINK
• 04582275711707: 250g, O PINK
• 04582275711684: 250g, LF PINK
• 04582275718911: 15g*20ml, A4
• 04582275718904: 15g*20ml, A1
• 04582275718898: 10kg, O-PINK
• 04582275718973: 10kg, V PINK
• 04582275718966: 10kg, LFα
• 04582594040588: 250g, MARBLE H
• 04582275718980: 250g, A4
• 04582594040847: 15g, O PINK