Barricaid® Visible Light Cure Periodontal Surgical Dressing 639052

GUDID D0026390524

Barricaid® Visible Light Cure Periodontal Surgical Dressing 4 Syringe Units

DENTSPLY INTERNATIONAL INC.

Clinical periodontal dressing

• Primary Device ID: D0026390524
• NIH Device Record Key: 3f497d6e-351c-4d55-950d-76e02f425723
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Barricaid® Visible Light Cure Periodontal Surgical Dressing
• Version Model Number: 639052
• Catalog Number: 639052
• Company DUNS: 083235549
• Company Name: DENTSPLY INTERNATIONAL INC.
• Device Count: 4
• DM Exempt: true
• 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: false
• 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

Customer Support Contacts

• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D0026390520 [Unit of Use]
HIBCC	D0026390524 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K864720

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: 2019-07-22
• Device Publish Date: 2019-07-12

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