OpaCem OPACEM8TR

GUDID D815OPACEM8TR0

OpaCem Dual Cure Resin Cement 8g syringe transparent

OPA DENTAL LLC

Dental composite resin

• Primary Device ID: D815OPACEM8TR0
• NIH Device Record Key: 5f14f928-6b37-41ed-b81b-6485706858cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OpaCem
• Version Model Number: OPACEM8TR
• Catalog Number: OPACEM8TR
• Company DUNS: 053308044
• Company Name: OPA DENTAL 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: 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
HIBCC	D815OPACEM8TR0 [Primary]

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: 2021-08-25
• Device Publish Date: 2021-08-17

Devices Manufactured by OPA DENTAL LLC

• D815VCR9814DARK0 - VEICRR: 2024-06-18 98mm x 14mm zirconia gingiva dark
• D815VCR9814LIGHT0 - VEICRR: 2024-06-18 98mm x 14mm zirconia gingiva light
• D815VCR9820DARK0 - VEICRR: 2024-06-18 98mm x 20mm zirconia gingiva dark
• D815VCR9820LIGHT0 - VEICRR: 2024-06-18 98mm x 20mm zirconia gingiva light
• D815OPAFILL4DO0 - OPA: 2023-12-22 Universal Composite Restorative 4g DO
• D815OPAFILL4DR0 - OPA: 2023-12-22 Universal Composite Restorative 4g DR
• D815OPAFILL4P20 - OPA: 2023-12-22 Universal Composite Restorative 4g P2
• D815OPAFLOW2DO0 - OPA: 2023-12-22 Composite Restorative Flowable 2g DO