SciPharm CuRay Support Light and Self Cure Composite Resin 55-304

GUDID D801SP55304N1

CuRay Support P/L - Self and Light Cured Core Build-Up Restorative. Activator Paste Syringe. Non-Boxed.

SCIENTIFIC PHARMACEUTICALS, INC.

Dental composite resin

• Primary Device ID: D801SP55304N1
• NIH Device Record Key: 8d0e206e-d55c-44c0-948a-cc427ed65dbe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SciPharm CuRay Support Light and Self Cure Composite Resin
• Version Model Number: SP 55-304 N
• Catalog Number: 55-304
• 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 Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D801SP55304N1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K912788

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: 2016-08-09

On-Brand Devices [SciPharm CuRay Support Light and Self Cure Composite Resin]

• D801SP55321: CuRay Support P/L - Self and Light Cured Core Build-Up Restorative. All Natural Shade Kit..
• D801SP55305N1: CuRay Support P/L - Self and Light Cured Core Build-Up Restorative. Dentin Liner. Non-Boxed.
• D801SP55305B1: CuRay Support P/L - Self and Light Cured Core Build-Up Restorative. Dentin Liner. Boxed.
• D801SP55304N1: CuRay Support P/L - Self and Light Cured Core Build-Up Restorative. Activator Paste Syringe. N
• D801SP55304B1: CuRay Support P/L - Self and Light Cured Core Build-Up Restorative. Activator Paste Syringe. B