Estelite Color

GUDID 04548190109128

White

TOKUYAMA DENTAL CORPORATION

Dental composite resin

• Primary Device ID: 04548190109128
• NIH Device Record Key: baa8d046-a8fc-4f57-b9e7-bdf7296043bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Estelite Color
• Version Model Number: 10912
• 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	04548190109128 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110178

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 Color ]

• 04548190109234: Low Chroma Opaque
• 04548190109227: Medium Chroma Opaque
• 04548190109210: High Chroma Opaque
• 04548190109203: Pink Opaque
• 04548190109197: Lavender
• 04548190109180: Red
• 04548190109173: Dark Brown
• 04548190109166: Ochre
• 04548190109159: Gray
• 04548190109142: Yellow
• 04548190109135: Blue
• 04548190109128: White
• 04548190109111: Clear
• 04548190109012: Kit