SciPharm CuRay Match Metal Primer 70-10

GUDID D801ID7010I1

SciPharm CuRay Match Metal Primer for Veneers or Cast Restorations (Primet). Boxed. Italian.

SCIENTIFIC PHARMACEUTICALS, INC.

Dental composite resin

• Primary Device ID: D801ID7010I1
• NIH Device Record Key: b1109e9a-0fdb-4718-b736-44d5f09b46ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SciPharm CuRay Match Metal Primer
• Version Model Number: ID 7010 I
• Catalog Number: 70-10
• Company DUNS: 096010525
• Company Name: SCIENTIFIC PHARMACEUTICALS, INC.
• 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

Customer Support Contacts

• Phone: 800-634-3047
• Email: Denise@scipharm.com
• Phone: 800-634-3047
• Email: Denise@scipharm.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D801ID7010I1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K884391

FDA Product Code

• EBF: Material, Tooth Shade, Resin

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-19

On-Brand Devices [SciPharm CuRay Match Metal Primer]

• D801SP7010SB1: SciPharm CuRay Match Metal Primer for Veneers or Cast Restorations (Primet). Boxed. Spanish.
• D801SP7010N1: SciPharm CuRay Match Metal Primer for Veneers or Cast Restorations (Primet). Non-Boxed.
• D801SP7010B1: SciPharm CuRay Match Metal Primer for Veneers or Cast Restorations (Primet). Boxed.
• D801ID7010I1: SciPharm CuRay Match Metal Primer for Veneers or Cast Restorations (Primet). Boxed. Italian.