Papacarie 610PAP100

GUDID 00858290006918

Papacarie Kit - 1 ml syringe

ELEVATE ORAL CARE, LLC

Dental coating, tooth-desensitizing, professional

• Primary Device ID: 00858290006918
• NIH Device Record Key: 66d4547d-c26a-4a76-bf16-10c18e3e0b6a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Papacarie
• Version Model Number: Papacarie Syringe
• Catalog Number: 610PAP100
• 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
• 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
• Total Volume: 0.4 Milliliter
• Total Volume: 0.4 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858290006918 [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

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