Metaltite

GUDID 04548190165476

TOKUYAMA DENTAL CORPORATION

Dental composite resin

• Primary Device ID: 04548190165476
• NIH Device Record Key: fc126c1e-515a-4f04-a07f-1bf4118c99f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Metaltite
• Version Model Number: 16547
• 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	04548190165476 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011685

FDA Product Code

• EMA: Cement, Dental

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

Devices Manufactured by TOKUYAMA DENTAL CORPORATION

• 04548190102242 - OMNICHROMA FLOW: 2024-11-04 SYRINGE SAMPLE KIT
• 04548190107629 - Brush No.24: 2022-10-03 Brush for composite
• 94548190122717 - PALFIQUE ESTELITE LV Syringe Tip: 2022-10-03 Dispensing tip for flowable composite
• 04548190127405 - TOKUYAMA Dispensing Tip: 2022-10-03 Dispensing tip for flowable composite
• 94548190137995 - TOKUYAMA Plastic Tip: 2022-10-03 Plastic dispensing tip for flowable composite
• 04548190146727 - Disposable Applicator Tip & Handle Set: 2022-10-03 Disposable Applicator Tip & Handle for One-Up Bond F Plus
• 94548190161938 - Cement Mixing Tip: 2022-10-03 Mixing tip for cement
• 04548190233724 - TOKUYAMA DISPENSER II: 2022-10-03 Dispensor for Sofreliner