Estelite Omega

GUDID 04548190107490

PLT DA3

TOKUYAMA DENTAL CORPORATION

Dental composite resin

• Primary Device ID: 04548190107490
• NIH Device Record Key: 00fedbc8-c768-4afd-b1f5-02e11b23ace0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Estelite Omega
• Version Model Number: 10749
• 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	04548190107490 [Primary]
GS1	94548190107493 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072746

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 Omega ]

• 04548190107513: PLT BL2
• 04548190107506: PLT BL1
• 04548190107490: PLT DA3
• 04548190107483: PLT DA2
• 04548190107476: PLT DA1
• 04548190107469: PLT MW
• 04548190107452: PLT Trans
• 04548190107445: PLT EB1
• 04548190107438: PLT EA3
• 04548190107421: PLT EA2
• 04548190107414: PLT EA1
• 04548190107315: Syringe BL2
• 04548190107308: Syringe BL1
• 04548190107292: Syringe DA3
• 04548190107285: Syringe DA2
• 04548190107278: Syringe DA1
• 04548190107261: Syringe MW
• 04548190107254: Syringe Trans
• 04548190107247: Syringe EB1
• 04548190107230: Syringe EA3
• 04548190107223: Syringe EA2
• 04548190107216: Syringe EA1
• 04548190107124: PLT Basic Kit
• 04548190107117: PLT Deluxe Kit
• 04548190107025: Syringe Basic Kit
• 04548190107018: Syringe Deluxe Kit