SciPharm Support Self Cured Core Build-Up Restorative 50-09

GUDID D801SP50091

Self-Curing Core Build-Up Restorative Paste/Paste Type

SCIENTIFIC PHARMACEUTICALS, INC.

Dental composite resin

• Primary Device ID: D801SP50091
• NIH Device Record Key: b5c816e9-d8c3-4b3e-a205-4f84ad1e788b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SciPharm Support Self Cured Core Build-Up Restorative
• Version Model Number: SP 50-09
• Catalog Number: 50-09
• 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

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	D801SP50091 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K823732

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: 2016-07-08

On-Brand Devices [SciPharm Support Self Cured Core Build-Up Restorative]

• D801SP55191: Self-Cured, Core Build-Up Composite Restorative Material. All Contrast Kit.
• D801SP5509S1: Self-Curing Core Build-Up Composite Restorative Material, Paste/Paste Type. 25g x 2 Support Kit
• D801SP550941: Self-Curing Core Build-Up Composite Restorative Material, Paste/Liquid Type. Part B, Catalyst B
• D801SP550921: Self-Curing Core Build-Up Composite Restorative Material, Paste/Paste Type. Part A, Natural Sha
• D801SP550911: Self-Curing Core Build-Up Composite Restorative Material, Paste/Paste Type. Part A, Contrast Pa
• D801SP55091: Self-Curing Core Build-Up Composite Restorative Material, Paste/Paste Type. 25g x 2 Support Kit
• D801SP50091: Self-Curing Core Build-Up Restorative Paste/Paste Type