Ambar APS

GUDID 07899633815913

4000019358 - AMBAR APS 6ML CE0086

Dentscare Ltda

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• Primary Device ID: 07899633815913
• NIH Device Record Key: 17f454cf-e7a7-4c6b-881d-9192c1ad6ee9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ambar APS
• Version Model Number: 6mL
• 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	07899633815913 [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

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• 07899633827206 - Whitepost System: 2023-06-16 A system of intraradicular posts that are radiopaque and made of a composite reinforced with fiberglass, recommended for endodon
• 07899633827688 - Whitepost System: 2023-06-16 A system of intraradicular posts that are radiopaque and made of a composite reinforced with fiberglass, recommended for endodon
• 07899633827695 - Whitepost System: 2023-06-16 A system of intraradicular posts that are radiopaque and made of a composite reinforced with fiberglass, recommended for endodon
• 07899633827701 - Whitepost System: 2023-06-16 A system of intraradicular posts that are radiopaque and made of a composite reinforced with fiberglass, recommended for endodon
• 07899633831005 - Whitepost System: 2023-06-16 A system of intraradicular posts that are radiopaque and made of a composite reinforced with fiberglass, recommended for endodon
• 07899633827145 - Whitepost System: 2023-06-15 A system of intraradicular posts that are radiopaque and made of a composite reinforced with fiberglass, recommended for endodon
• 07899633827169 - Whitepost System: 2023-06-15 A system of intraradicular posts that are radiopaque and made of a composite reinforced with fiberglass, recommended for endodon