Estelite Flow Quick High Flow

GUDID 04548190120826

PLT A2

TOKUYAMA DENTAL CORPORATION

Dental composite resin

• Primary Device ID: 04548190120826
• NIH Device Record Key: a71db7d7-5b62-4c77-b7ca-74ef36fa68fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Estelite Flow Quick High Flow
• Version Model Number: 12082
• Company DUNS: 693552176
• Company Name: TOKUYAMA DENTAL CORPORATION
• Device Count: 20
• 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

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	04548190120826 [Primary]
GS1	94548190120829 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051808

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 [Estelite Flow Quick High Flow ]

• 04548190123919: Syringe A2 Mini
• 04548190121748: Syringe OPA2
• 04548190121731: Syringe A3
• 04548190121724: Syringe A2
• 04548190121717: Syringe A1
• 04548190120840: PLT OPA2
• 04548190120833: PLT A3
• 04548190120826: PLT A2
• 04548190120819: PLT A1