All Smiles Style 4000055353

GUDID 07899633827398

All Smiles Style is a radiopaque composite for anterior and posterior restorations.

Dentscare Ltda

Dental composite resin

• Primary Device ID: 07899633827398
• NIH Device Record Key: 8e8e2292-8873-4de9-950b-b3ea002f7a8f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: All Smiles Style
• Version Model Number: EA1 4g
• Catalog Number: 4000055353
• 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	07899633827398 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191306

FDA Product Code

• EBF: Material, Tooth Shade, 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: 2021-04-07
• Device Publish Date: 2021-03-30

On-Brand Devices [All Smiles Style]

• 07899633827398: All Smiles Style is a radiopaque composite for anterior and posterior restorations.
• 07899633827381: All Smiles Style is a radiopaque composite for anterior and posterior restorations.
• 07899633827374: All Smiles Style is a radiopaque composite for anterior and posterior restorations.
• 07899633827367: All Smiles Style is a radiopaque composite for anterior and posterior restorations.
• 07899633827350: All Smiles Style is a radiopaque composite for anterior and posterior restorations.
• 07899633828432: All Smiles Style is a radiopaque composite for anterior and posterior restorations.
• 07899633828418: All Smiles Style is a radiopaque composite for anterior and posterior restorations.
• 07899633828401: All Smiles Style is a radiopaque composite for anterior and posterior restorations.
• 07899633828395: All Smiles Style is a radiopaque composite for anterior and posterior restorations.
• 07899633828388: All Smiles Style is a radiopaque composite for anterior and posterior restorations.