OMNICHROMA FLOW BULK

GUDID 04548190102211

SYRINGE

TOKUYAMA DENTAL CORPORATION

Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin

• Primary Device ID: 04548190102211
• NIH Device Record Key: 9ecb822e-72ed-4789-92cb-a7593504247d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OMNICHROMA FLOW BULK
• Version Model Number: 10221
• 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
• Phone: 1-877-378-3548
• Email: info@tokuyama-us.com
• Phone: 1-877-378-3548
• Email: info@tokuyama-us.com
• Phone: 1-877-378-3548
• Email: info@tokuyama-us.com
• Phone: 1-877-378-3548
• Email: info@tokuyama-us.com
• Phone: 1-877-378-3548
• Email: info@tokuyama-us.com
• Phone: 1-877-378-3548
• Email: info@tokuyama-us.com
• Phone: 1-877-378-3548
• Email: info@tokuyama-us.com
• Phone: 1-877-378-3548
• Email: info@tokuyama-us.com
• Phone: 1-877-378-3548
• Email: info@tokuyama-us.com
• Phone: 1-877-378-3548
• Email: info@tokuyama-us.com
• Phone: 1-877-378-3548
• Email: info@tokuyama-us.com
• Phone: 1-877-378-3548
• Email: info@tokuyama-us.com
• 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
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04548190102211 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203598

FDA Product Code

• EBF: Material, Tooth Shade, Resin

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: 2021-03-23
• Device Publish Date: 2021-03-15

On-Brand Devices [OMNICHROMA FLOW BULK]

• 04548190102259: TRIAL SYRINGE
• 04548190102211: SYRINGE