Smart Advantage GI A1 ampule

GUDID 00858290006369

Smart Advantage GI A1 ampule

ELEVATE ORAL CARE, LLC

Glass ionomer dental cement

• Primary Device ID: 00858290006369
• NIH Device Record Key: 91a600dc-0fdd-4a38-9ecf-405453736f48
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Smart Advantage GI A1 ampule
• Version Model Number: 575CAPA1S
• 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: false
• 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	00858290006338 [Package]; Package: kit [30 Units]; In Commercial Distribution
GS1	00858290006352 [Package]; Package: kit [15 Units]; In Commercial Distribution
GS1	00858290006369 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K895386

FDA Product Code

• EMA: Cement, Dental

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-10-15
• Device Publish Date: 2019-06-10

Devices Manufactured by ELEVATE ORAL CARE, LLC

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• 00858290006734 - FluoriMax Cotton Candy: 2024-12-20 FluoriMax 2.5% NaF Varnish Cotton Candy Flavor flow through ampoules 70 pack
• 00858290006918 - Papacarie: 2024-12-20 Papacarie Kit - 1 ml syringe
• 00858290006932 - Povi-One: 2024-12-20 Povi-One/FluoriMax Varnish BG Convenience Bottle Kit - 8ml bottle
• 00858290006598 - DenteShield Sample Opaque with Fluoride: 2024-12-03 DenteShield Sample Opaque with Fluoride
• 00858290006895 - Povi-One: 2023-10-05 Povi-One Unit Dose, .45ml, Demo 2pk
• 00858290006888 - Advantage Arrest: 2023-07-31 Advantage Arrest, Convenience Kit