International Dental Supply CuRay Match Visible Light Cure Composite Restorative 65-021

GUDID D801ID65021I1

Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix. Primer. Italian.

SCIENTIFIC PHARMACEUTICALS, INC.

Dentine adhesive

• Primary Device ID: D801ID65021I1
• NIH Device Record Key: 1950c874-1173-48da-bbf6-854dacd4e867
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: International Dental Supply CuRay Match Visible Light Cure Composite Restorative
• Version Model Number: ID 65-021 I
• Catalog Number: 65-021
• 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	D801ID65021I1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K791132

FDA Product Code

• DYH: Adhesive, Bracket And Tooth Conditioner, 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

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• D801ID65024I1: Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Syringe. Italia
• D801ID65021I1: Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix. Primer. Itali
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• D801ID50215I1: CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Sh
• D801ID50214I1: CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Sh
• D801ID50213I1: CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Sh
• D801ID50212I1: CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Sh
• D801ID50211I1: CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Sh
• D801ID50210I1: CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Sh