Smart Advantage GI A1 and A2 Combo kit 30 ampules

GUDID 00858290006437

Smart Advantage GI A1 and A2 Combo kit 30 ampules

ELEVATE ORAL CARE, LLC

Glass ionomer dental cement

• Primary Device ID: 00858290006437
• NIH Device Record Key: 734a03c8-0242-48da-8e27-951e2129c1f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Smart Advantage GI A1 and A2 Combo kit 30 ampules
• Version Model Number: 675COMB00
• 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	00858290006352 [Primary]
GS1	00858290006420 [Package]; Contains: 00858290006352; Package: kit [15 Units]; In Commercial Distribution
GS1	00858290006437 [Package]; Contains: 00858290006352; Package: kit [15 Units]; In Commercial Distribution

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-22
• Device Publish Date: 2019-10-14

Devices Manufactured by ELEVATE ORAL CARE, LLC

• 00858290006895 - Povi-One: 2023-10-05 Povi-One Unit Dose, .45ml, Demo 2pk
• 00858290006888 - Advantage Arrest: 2023-07-31 Advantage Arrest, Convenience Kit
• 00858290006871 - Allday Spray/Gel Sample Bag: 2023-05-26 Dry Mouth Spray and Gel, Mint, 1.5oz Bottle and Tube, Sample Bag
• 00858290006758 - FluoriMax 2.5% NaF Varnish: 2022-11-07 FluoriMax 2.5% NaF Varnish 1 Bottle Kit Bubble Gum
• 00858290006765 - FluoriMax 2.5% NaF Varnish: 2022-11-07 FluoriMax 2.5% NaF Varnish 1 Bottle Kit Mint
• 00858290006772 - FluoriMax 2.5% NaF Varnish: 2022-11-07 FluoriMax 2.5% NaF Varnish 1 Bottle Kit Caramel
• 00858290006789 - FluoriMax 2.5% NaF Varnish 1 Bottle Kit Unflavored: 2022-11-07 FluoriMax 2.5% NaF Varnish 1 Bottle Kit Unflavored
• 00858290006796 - FluoriMax 2.5% NaF Varnish 1 Bottle Kit Cotton Candy: 2022-11-07 FluoriMax 2.5% NaF Varnish 1 Bottle Kit Cotton Candy