Vista-Red Caries 10ml Kit

GUDID 10818207020052

Glycol based solution to facilitate removal of carious dentin. Kit includes 10ml bottle, (6) mixing wells & (24) micro-applicator brushes

Vista Dental

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• Primary Device ID: 10818207020052
• NIH Device Record Key: db52ccd2-9785-4090-8ec2-552bf38c3870
• Commercial Distribution Discontinuation: 2021-07-01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vista-Red Caries 10ml Kit
• Version Model Number: 503409
• Company DUNS: 036623932
• Company Name: Vista Dental
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10818207020052 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955445

FDA Product Code

• LFC: Device, Caries Detection

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-02-01
• Device Publish Date: 2018-06-19

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