International Dental Supply Support Self Cured Core Build-Up Restorative 55-304

GUDID D801ID55304I1

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

SCIENTIFIC PHARMACEUTICALS, INC.

Dental composite resin Dental composite resin

• Primary Device ID: D801ID55304I1
• NIH Device Record Key: 879f8026-8b66-4d9b-8a7b-57825a998517
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: International Dental Supply Support Self Cured Core Build-Up Restorative
• Version Model Number: ID 55-304 I
• 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 Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 23 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D801ID55304I1 [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: 2016-08-11

On-Brand Devices [International Dental Supply Support Self Cured Core Build-Up Restorative]

• D801ID55304I1: CuRay Support P/L - Self and Light Cured Core Build-Up Restorative. Activator Paste Syringe. B
• D801ID55303I1: CuRay Support P/L - Self and Light Cured Core Build-Up Restorative. Activator Liquid Bottle. I
• D801ID55302I1: CuRay Support P/L - Self and Light Cured Core Build-Up Restorative. Part A, Natural Syringe. B
• D801ID55301I1: CuRay Support P/L - Self and Light Cured Core Build-Up Restorative. Contrast Syringe. Boxed.