SciPharm NewCore, Core Build-Up Restorative Automix 57-013

GUDID D801SP57013TN1

NewCore - Core Build-Up Restorative Material in Automix Cartridges. 50 cc Dual Barrel Cartridge. Blue Shade. Trial Size. Non-Boxed.

SCIENTIFIC PHARMACEUTICALS, INC.

Dental composite resin

• Primary Device ID: D801SP57013TN1
• NIH Device Record Key: f9ee3ed9-ec86-40b9-b5cb-a82ec515d084
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SciPharm NewCore, Core Build-Up Restorative Automix
• Version Model Number: SP 57-013 TN
• Catalog Number: 57-013
• 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	D801SP57013TN1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K810479

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 NewCore, Core Build-Up Restorative Automix]

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• D801SP57021: NewCore - Core Build-Up Restorative Material in Automix Cartridges. 50 cc Dual Barrel Cartridge
• D801SP57013TN1: NewCore - Core Build-Up Restorative Material in Automix Cartridges. 50 cc Dual Barrel Cartridge
• D801SP57013T1: NewCore - Core Build-Up Restorative Material in Automix Cartridges. 50 cc Dual Barrel Cartridge
• D801SP57013N1: NewCore - Core Build-Up Restorative Material in Automix Cartridges. 50 cc Dual Barrel Cartridge
• D801SP57012N1: NewCore - Core Build-Up Restorative Material in Automix Cartridges. 50 cc Dual Barrel Cartridge
• D801SP57011N1: NewCore - Core Build-Up Restorative Material in Automix Cartridges. 50 cc Dual Barrel Cartridge
• D801SP57011: NewCore - Core Build-Up Restorative Material in Automix Cartridges. 50 cc Dual Barrel Cartridge
• D801SP51302CB1: Newcore - Light-Cured Core Build-Up Restoratives in Automix Cartridges, Paste. Carpule. Boxed.
• D801SP51302C1: Newcore - Light-Cured Core Build-Up Restoratives in Automix Cartridges, Paste. Carpule
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• D801SP51091: Newcore - Light-Cured Core Build-Up Restoratives in Automix Cartridges, Contrast Shade, 25 grams