Estelite Bulk Fill Flow

GUDID 04548190127443

PLT Mini Kit

TOKUYAMA DENTAL CORPORATION

Dental composite resin

• Primary Device ID: 04548190127443
• NIH Device Record Key: be027f8c-e664-421a-9940-dcd5b4fce683
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Estelite Bulk Fill Flow
• Version Model Number: 12744
• 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: true
• 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	04548190127443 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161353

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: 2017-08-01

On-Brand Devices [Estelite Bulk Fill Flow]

• 04548190127443: PLT Mini Kit
• 04548190127399: PLT A3
• 04548190127382: PLT A2
• 04548190127375: PLT A1
• 04548190127368: PLT B1
• 04548190127351: PLT U
• 04548190127191: Syringe A3
• 04548190127184: Syringe A2
• 04548190127177: Syringe A1
• 04548190127160: Syringe B1
• 04548190127153: Syringe U