Ambar Universal APS

GUDID 07899633815944

4000019361 - AMBAR UNIV APS 5ML CE0086

Dentscare Ltda

Dentine bonding agent/set

• Primary Device ID: 07899633815944
• NIH Device Record Key: b7ebeac1-f381-44df-bc6e-7d62f8c671b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ambar Universal APS
• Version Model Number: 5mL
• Company DUNS: 898067533
• Company Name: Dentscare Ltda
• 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: 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	07899633815944 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183424

FDA Product Code

• KLE: Agent, Tooth Bonding, Resin

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: 2020-02-10
• Device Publish Date: 2020-01-31

Devices Manufactured by Dentscare Ltda

• 07899633835249 - PrimmaArt: 2025-04-16 PrimmaArt is a self-curing composite that is highly efficient for the fabrication of temporary restorations for indirect dental
• 07899633835256 - PrimmaArt: 2025-04-16 PrimmaArt is a self-curing composite that is highly efficient for the fabrication of temporary restorations for indirect dental
• 07899633835263 - PrimmaArt: 2025-04-16 PrimmaArt is a self-curing composite that is highly efficient for the fabrication of temporary restorations for indirect dental
• 07899633835270 - PrimmaArt: 2025-04-16 PrimmaArt is a self-curing composite that is highly efficient for the fabrication of temporary restorations for indirect dental
• 07899633835287 - PrimmaArt: 2025-04-16 PrimmaArt is a self-curing composite that is highly efficient for the fabrication of temporary restorations for indirect dental
• 07899633835294 - PrimmaArt: 2025-04-16 PrimmaArt is a self-curing composite that is highly efficient for the fabrication of temporary restorations for indirect dental
• 07899633835300 - PrimmaArt: 2025-04-16 PrimmaArt is a self-curing composite that is highly efficient for the fabrication of temporary restorations for indirect dental
• 07899633835317 - PrimmaArt: 2025-04-16 PrimmaArt is a self-curing composite that is highly efficient for the fabrication of temporary restorations for indirect dental