OMNICHROMA

GUDID 04548190101269

PLT

TOKUYAMA DENTAL CORPORATION

Dental composite resin

• Primary Device ID: 04548190101269
• NIH Device Record Key: 8caeac50-d3f6-4e34-8f10-d1d2e7ec0c54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OMNICHROMA
• Version Model Number: 10126
• 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	04548190101269 [Primary]
GS1	94548190101262 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173275

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: 2018-10-11
• Device Publish Date: 2018-09-10

On-Brand Devices [OMNICHROMA]

• 04548190101511: PLT SAMPLE KIT
• 04548190101412: SYRINGE SAMPLE KIT
• 04548190101320: Syringe Sample
• 04548190101306: PLT Sample
• 04548190101269: PLT
• 04548190101160: SYRINGE