Refine Bright

GUDID 04582594040847

YAMAHACHI DENTAL MFG.,CO.

Dental prosthesis restorative material, unfilled resin

• Primary Device ID: 04582594040847
• NIH Device Record Key: 57d9405e-202d-4379-aa7b-e168c67bee32
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Refine Bright
• Version Model Number: 15g, 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	04582594040847 [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: 2021-11-29
• Device Publish Date: 2021-11-20

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