Palfique Estelite LV

GUDID 04548190123124

High Flow A2

TOKUYAMA DENTAL CORPORATION

Dental composite resin

• Primary Device ID: 04548190123124
• NIH Device Record Key: ec8bf19c-7cfe-4049-bb07-2732b9bb73e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Palfique Estelite LV
• Version Model Number: 12312
• Company DUNS: 693552176
• Company Name: TOKUYAMA DENTAL CORPORATION
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-877-378-3548
• Email: info@tokuyama-us.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04548190123124 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002863

FDA Product Code

• EBF: Material, Tooth Shade, Resin

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: 2016-09-23

On-Brand Devices [Palfique Estelite LV ]

• 04548190123247: Medium Flow A3.5
• 04548190123230: Medium Flow A3
• 04548190123223: Medium Flow A2
• 04548190123216: Medium Flow A1
• 04548190123186: Low Flow A3
• 04548190123179: Low Flow A2
• 04548190123162: Low Flow A1
• 04548190123131: High Flow A3
• 04548190123124: High Flow A2
• 04548190123117: High Flow A1