Povi-One 640POFM80

GUDID 00858290006932

Povi-One/FluoriMax Varnish BG Convenience Bottle Kit - 8ml bottle

ELEVATE ORAL CARE, LLC

Dental coating, tooth-desensitizing, professional

• Primary Device ID: 00858290006932
• NIH Device Record Key: 30b26f1a-4301-43de-aadd-f9d01fd37136
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Povi-One
• Version Model Number: Povi-One/FluoriMax Varnish BG Convenience
• Catalog Number: 640POFM80
• Company DUNS: 002863526
• Company Name: ELEVATE ORAL CARE, LLC
• 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: 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

Device Dimensions

• Total Volume: 0.4 Milliliter
• Total Volume: 0.4 Milliliter
• Total Volume: 0.4 Milliliter
• Total Volume: 0.4 Milliliter
• Total Volume: 0.4 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858290006932 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131376

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: 2024-12-20
• Device Publish Date: 2024-12-12

On-Brand Devices [Povi-One]

• 00858290006895: Povi-One Unit Dose, .45ml, Demo 2pk
• 00858290006932: Povi-One/FluoriMax Varnish BG Convenience Bottle Kit - 8ml bottle