SciPharm CuRay Fil Light Cure Composite Resin 50-121

GUDID D801SP501211

Visible Light-Cured Restorative, Resin Based. Universal Bonding Agent. Boxed

SCIENTIFIC PHARMACEUTICALS, INC.

Dental composite resin

• Primary Device ID: D801SP501211
• NIH Device Record Key: 5fd05f98-8dd5-4b00-abdb-18bcda830c0b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SciPharm CuRay Fil Light Cure Composite Resin
• Version Model Number: SP 50-121
• Catalog Number: 50-121
• 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 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D801SP501211 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K850675

FDA Product Code

• EBD: Coating, Filling Material, 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: 2016-07-29

On-Brand Devices [SciPharm CuRay Fil Light Cure Composite Resin]

• D801SP5510S1: Visible Light-Cured, Highly Filled Composite Restorative for use Primarily in Class I and Class
• D801SP5510C1: Visible Light-Cured, Highly Filled Composite Restorative for use Primarily in Class I and Class
• D801SP551021: Visible Light-Cured, Highly Filled Composite Restorative for use Primarily in Class I and Class
• D801SP551011: Visible Light-Cured, Highly Filled Composite Restorative for use Primarily in Class I and Class
• D801SP50125BS1: Visible Light-Cured Composite Restorative, Resin Based. With Bonding Agent. Shade A2, Boxed, S
• D801SP50125B1: Visible Light-Cured Composite Restorative, Resin Based. With Bonding Agent. Shade A2, Boxed
• D801SP50122N1: Visible Light-Cured Restorative, Resin Based. Dentin Conditioner Bottle. Non-Boxed
• D801SP50122B1: Visible Light-Cured Restorative, Resin Based. Dentin Conditioner Bottle. Boxed
• D801SP50121N1: Visible Light-Cured Restorative, Resin Based. Universal Bonding Agent. Non-Boxed
• D801SP501211: Visible Light-Cured Restorative, Resin Based. Universal Bonding Agent. Boxed
• D801SP50120S1: Visible Light-Cured Restorative, Resin Based. Dentin Enamel Bonding System. Spanish
• D801SP501201: Visible Light-Cured Restorative, Resin Based. Dentin Enamel Bonding System.
• D801SP50115N1: Visible Light-Cured Restorative, Resin Based. Shade A3.5, Non-Boxed
• D801SP50115CBS201: Visible Light-Cured Restorative, Resin Based. Shade A3.5, Boxed, 20 Carpules
• D801SP50115CB1: Visible Light-Cured Restorative, Resin Based. Shade A3.5, Boxed, Carpule.
• D801SP50115C1: Visible Light-Cured Restorative, Resin Based. Shade A3.5, Carpule
• D801SP50115BS1: Visible Light-Cured Restorative, Resin Based. Shade A3.5, Boxed, Spanish.
• D801SP50115B1: Visible Light-Cured Restorative, Resin Based. Shade A3.5, Boxed.
• D801SP50114N1: Visible Light-Cured Restorative, Resin Based. Shade A3, Non-Boxed
• D801SP50114CBS201: Visible Light-Cured Restorative, Resin Based. Shade A3, Boxed, 20 Carpules
• D801SP50114CB1: Visible Light-Cured Restorative, Resin Based. Shade A3, Boxed, Carpule
• D801SP50114C1: Visible Light-Cured Restorative, Resin Based. Shade A3, Carpule
• D801SP50114BS1: Visible Light-Cured Restorative, Resin Based. Shade A3, Boxed, Spanish
• D801SP50114B1: Visible Light-Cured Restorative, Resin Based. Shade A3, Boxed
• D801SP50113N1: Visible Light-Cured Restorative, Resin Based. Shade A4, Non-Boxed
• D801SP50113CB1: Visible Light-Cured Restorative, Resin Based. Shade A4, Boxed, Carpule
• D801SP50113C1: Visible Light-Cured Restorative, Resin Based. Shade A4, Carpule
• D801SP50113BS1: Visible Light-Cured Restorative, Resin Based. Shade A4, Boxed, Spanish
• D801SP50113B1: Visible Light-Cured Restorative, Resin Based. Shade A4, Boxed.
• D801SP50112N1: Visible Light-Cured Restorative, Resin Based. Shade C4, Non-Boxed
• D801SP50112CB1: Visible Light-Cured Restorative, Resin Based. Shade C4, Boxed, Carpule
• D801SP50112C1: Visible Light-Cured Restorative, Resin Based. Shade C4, Carpule
• D801SP50112BS1: Visible Light-Cured Restorative, Resin Based. Shade C4, Boxed, Spanish
• D801SP50112B1: Visible Light-Cured Restorative, Resin Based. Shade C4, Boxed
• D801SP50110N1: Visible Light-Cured Dentin Enamel Bonding Agent, Resin Based. Non-Boxed
• D801SP50110B1: Visible Light-Cured Dentin Enamel Bonding Agent, Resin Based. Boxed
• D801SP50109N1: Visible Light-Cured Bonding Agent, Resin Based. Non-Boxed
• D801SP50109B1: Visible Light-Cured Bonding Agent, Resin Based. Boxed
• D801SP50107N1: Visible Light-Cured Restorative, Resin Based. Shade B3, Non-Boxed
• D801SP50107CB1: Visible Light-Cured Restorative, Resin Based. Shade B3, Boxed, Carpules
• D801SP50107C1: Visible Light-Cured Restorative, Resin Based. Shade B3, Carpule
• D801SP50107BS1: Visible Light-Cured Restorative, Resin Based. Shade B3, Boxed, Spanish
• D801SP50107B1: Visible Light-Cured Restorative, Resin Based. Shade B3, Boxed
• D801SP50106N1: Visible Light-Cured Restorative, Resin Based. Shade D3, Non-Boxed
• D801SP50106CBS201: Visible Light-Cured Restorative, Resin Based. Shade D3, Boxed, 20 Carpules
• D801SP50106CB1: Visible Light-Cured Restorative, Resin Based. Shade D3, Boxed, Carpules
• D801SP50106C1: Visible Light-Cured Restorative, Resin Based. Shade D3, Carpule
• D801SP50106BS1: Visible Light-Cured Restorative, Resin Based. Shade D3, Boxed, Spanish
• D801SP50106B1: Visible Light-Cured Restorative, Resin Based. Shade D3, Boxed
• D801SP50105N1: Visible Light-Cured Restorative, Resin Based. Shade B2, Non-Boxed