Tokuyama Shield Force Plus

GUDID 04548190151110

Kit

TOKUYAMA DENTAL CORPORATION

Dental cavity varnish

• Primary Device ID: 04548190151110
• NIH Device Record Key: 33424d6d-097c-435b-814a-0d5141b42bca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tokuyama Shield Force Plus
• Version Model Number: 15111
• 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: true
• 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	04548190151110 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100172

FDA Product Code

• LBH: Varnish, Cavity

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-09-23

On-Brand Devices [Tokuyama Shield Force Plus]

• 04548190151417: Mini-kit
• 04548190151219: Refill
• 04548190151110: Kit