BIstite II DC

GUDID 04548190163373

Primer 1B

TOKUYAMA DENTAL CORPORATION

Dental composite resin

• Primary Device ID: 04548190163373
• NIH Device Record Key: 7f9d5566-7648-44b8-a297-8433eb9e8823
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIstite II DC
• Version Model Number: 16337
• 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 10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04548190163373 [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

On-Brand Devices [BIstite II DC ]

• 04548190163717: Air Barrier
• 04548190163380: Primer 2
• 04548190163373: Primer 1B
• 04548190163366: Primer 1A
• 04548190163137: Paste Dentin
• 04548190163120: Paste Ivory
• 04548190163113: Paste Clear
• 04548190163083: Kit Dentin
• 04548190163076: Kit Ivory
• 04548190163069: Kit Clear