SciPharm Anterior/Posterior Restoratives 51-12

GUDID D801SP51121

CuRay II - Visible Light-Cured, Highly Filled Composite Restorative For Use Primarily in Class I and Class II Restorations. Shade A3/A3.5.

SCIENTIFIC PHARMACEUTICALS, INC.

Dental composite resin

• Primary Device ID: D801SP51121
• NIH Device Record Key: 6ca5c9a8-fb12-444f-87de-1af0714fc9fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SciPharm Anterior/Posterior Restoratives
• Version Model Number: SP 51-12
• Catalog Number: 51-12
• 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 Humidity: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D801SP51121 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K823510

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: 2016-08-03

On-Brand Devices [SciPharm Anterior/Posterior Restoratives]

• D801SP56161: Anterior / Posterior Resin-Based Restorative Material. Paste/Paste Type. Multiple Unit. 14 gra
• D801SP56151: Anterior / Posterior Resin-Based Restorative Material. Paste/Paste Type. Multiple Unit. 14 gra
• D801SP5504S1: Visible Light-Cured, Resin-Based Composite Restorative Paste/Paste Type without Bonding Agent.
• D801SP550421: Visible Light-Cured, Resin-Based Composite Restorative Paste/Paste Type without Bonding Agent.
• D801SP550411: Visible Light-Cured, Resin-Based Composite Restorative Paste/Paste Type without Bonding Agent.
• D801SP55041: Visible Light-Cured, Resin-Based Composite Restorative Paste/Paste Type without Bonding Agent.
• D801SP5405S1: Visible Light-Cured, Resin-Based Composite Restorative Paste/Paste Type. 12 grams. Spanish
• D801SP54051: Visible Light-Cured, Resin-Based Composite Restorative Paste/Paste Type. 12 grams.
• D801SP5404S1: Visible Light-Cured, Resin-Based Composite Restorative Paste/Paste Type. 7 grams. Spanish
• D801SP540421: Visible Light-Cured, Resin-Based Composite Restorative Paste/Paste Type. 7 gram Jar, Part B.
• D801SP540411: Visible Light-Cured, Resin-Based Composite Restorative Paste/Paste Type. 7 gram Jar, Part A.
• D801SP54041: Visible Light-Cured, Resin-Based Composite Restorative Paste/Paste Type.. 7 grams.
• D801SP51201: CuRay II - Visible Light-Cured, Highly Filled Composite Restorative For Use Primarily in Class I
• D801SP51121: CuRay II - Visible Light-Cured, Highly Filled Composite Restorative For Use Primarily in Class I
• D801SP51111: CuRay II - Visible Light-Cured, Highly Filled Composite Restorative For Use Primarily in Class I
• D801SP5110S1: CuRay II - Visible Light-Cured, Highly Filled Composite Restorative For Use Primarily in Class I
• D801SP51101: CuRay II - Visible Light-Cured, Highly Filled Composite Restorative For Use Primarily in Class I
• D801SP510121: CuRay Fil Visible Light-Cured Restorative, Resin-Based. A No-Compromise, Highly Polishable, Hyb
• D801SP50504CB1: CuRay II - Visible Light-Cured, Highly Filled Composite Restorative For Use Primarily in Class I
• D801SP50504C1: CuRay II - Visible Light-Cured, Highly Filled Composite Restorative For Use Primarily in Class I
• D801SP50503CB1: CuRay II - Visible Light-Cured, Highly Filled Composite Restorative For Use Primarily in Class I
• D801SP50503C1: CuRay II - Visible Light-Cured, Highly Filled Composite Restorative For Use Primarily in Class I
• D801SP50502CB1: CuRay II - Visible Light-Cured, Highly Filled Composite Restorative For Use Primarily in Class I
• D801SP50502C1: CuRay II - Visible Light-Cured, Highly Filled Composite Restorative For Use Primarily in Class I
• D801SP50501CB1: CuRay II - Visible Light-Cured, Highly Filled Composite Restorative For Use Primarily in Class I
• D801SP50501C1: CuRay II - Visible Light-Cured, Highly Filled Composite Restorative For Use Primarily in Class I
• D801SP50041: Visible Light-Cured, Highly Filled Composite Restorative For Use Primarily in Class I and Class