Opus Bulk Fill APS

GUDID 07899633816033

19370 - RESINA OPUS B FILL APS A3 4G - REFIL CE

Dentscare Ltda

Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin

• Primary Device ID: 07899633816033
• NIH Device Record Key: 9a99060e-1b35-4354-820f-37daa4412f4d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Opus Bulk Fill APS
• Version Model Number: A3 4g
• 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	07899633816033 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190758

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: 2019-11-12
• Device Publish Date: 2019-11-04

On-Brand Devices [Opus Bulk Fill APS]

• 07899633816033: 19370 - RESINA OPUS B FILL APS A3 4G - REFIL CE
• 07899633816026: 19369 - RESINA OPUS B FILL APS A2 4G - REFIL CE
• 07899633816019: 19368 - RESINA OPUS B FILL APS A1 4G - REFIL CE