Estelite Flow Quick

GUDID 04548190120215

PLT A1

TOKUYAMA DENTAL CORPORATION

Dental composite resin

• Primary Device ID: 04548190120215
• NIH Device Record Key: 6bff673d-74b5-4baf-87ee-0dd7f99240c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Estelite Flow Quick
• Version Model Number: 12021
• 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	04548190120215 [Primary]
GS1	94548190120218 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051808

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 Flow Quick ]

• 04548190123810: Syringe A2 Mini
• 04548190121274: Syringe BW
• 04548190121267: Syringe CE(Incisal)
• 04548190121250: Syringe OA3
• 04548190121243: Syringe OA2
• 04548190121236: Syringe OA1
• 04548190121229: Syringe C3
• 04548190121212: Syringe C2
• 04548190121205: Syringe C1
• 04548190121199: Syringe B4
• 04548190121182: Syringe B3
• 04548190121175: Syringe B2
• 04548190121168: Syringe B1
• 04548190121151: Syringe A4(Cervical)
• 04548190121144: Syringe A3.5
• 04548190121137: Syringe A3
• 04548190121120: Syringe A2
• 04548190121113: Syringe A1
• 04548190120376: PLT BW
• 04548190120369: PLT CE(Incisal)
• 04548190120352: PLT OA3
• 04548190120345: PLT OA2
• 04548190120338: PLT OA1
• 04548190120321: PLT C3
• 04548190120314: PLT C2
• 04548190120307: PLT C1
• 04548190120291: PLT B4
• 04548190120284: PLT B3
• 04548190120277: PLT B2
• 04548190120260: PLT B1
• 04548190120253: PLT A4(Cervical)
• 04548190120246: PLT A3.5
• 04548190120239: PLT A3
• 04548190120222: PLT A2
• 04548190120215: PLT A1