FLUORIDEX VN200ST

GUDID D813VN200ST1

FLX VARNISH STRAWBERRY 200PK

DEN-MAT HOLDINGS, LLC

Dental coating, tooth-desensitizing

• Primary Device ID: D813VN200ST1
• NIH Device Record Key: e7868e71-2157-4901-9152-16cc5bc6ff2f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FLUORIDEX
• Version Model Number: VN200ST
• Catalog Number: VN200ST
• Company DUNS: 809857704
• Company Name: DEN-MAT HOLDINGS, LLC
• Device Count: 200
• 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: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D813VN200ST0 [Unit of Use]
HIBCC	D813VN200ST1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K124025

FDA Product Code

• LBH: Varnish, Cavity

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-24
• Device Publish Date: 2019-06-14

On-Brand Devices [FLUORIDEX]

• D813VN205S0: VARNISH STRAWBERRY IN BAG
• D813VN200ST1: FLX VARNISH STRAWBERRY 200PK