SciPharm Fluoroseal Cavity Liner 75-031

GUDID D801SP750351

Fluoroseal is a Light-Cured Cavity Liner used for Building the Cavity Floor in Deep Restorations. Also Provide Protection Against Irritants from Restoratives or Auxiliary Materials. Dentin Shade Syringe. Non-Boxed.

SCIENTIFIC PHARMACEUTICALS, INC.

Dental cavity varnish

• Primary Device ID: D801SP750351
• NIH Device Record Key: 4aac05dd-ce67-4eab-bafc-a215037f0028
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SciPharm Fluoroseal Cavity Liner
• Version Model Number: SP 75-035
• Catalog Number: 75-031
• 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	D801SP750351 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K860633

FDA Product Code

• LBH: Varnish, Cavity

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

On-Brand Devices [SciPharm Fluoroseal Cavity Liner]

• D801SP75131N1: Fluoroseal is a Light-Cured Cavity Liner used for Building the Cavity Floor in Deep Restorations
• D801SP75131BS1: Fluoroseal is a Light-Cured Cavity Liner used for Building the Cavity Floor in Deep Restorations
• D801SP75131B1: Fluoroseal is a Light-Cured Cavity Liner used for Building the Cavity Floor in Deep Restorations
• D801SP75131: Fluoroseal is a Light-Cured Cavity Liner used for Building the Cavity Floor in Deep Restorations
• D801SP7503S1: Fluoroseal is a Light-Cured Cavity Liner used for Building the Cavity Floor in Deep Restorations
• D801SP75036B1: Fluoroseal is a Light-Cured Cavity Liner used for Building the Cavity Floor in Deep Restorations
• D801SP75035Z1: Fluoroseal is a Light-Cured Cavity Liner used for Building the Cavity Floor in Deep Restorations
• D801SP75035BS1: Fluoroseal is a Light-Cured Cavity Liner used for Building the Cavity Floor in Deep Restorations
• D801SP75035B1: Fluoroseal is a Light-Cured Cavity Liner used for Building the Cavity Floor in Deep Restorations
• D801SP750351: Fluoroseal is a Light-Cured Cavity Liner used for Building the Cavity Floor in Deep Restorations
• D801SP75031NB1: Fluoroseal is a Light-Cured Cavity Liner used for Building the Cavity Floor in Deep Restorations
• D801SP75031BS1: Fluoroseal is a Light-Cured Cavity Liner used for Building the Cavity Floor in Deep Restorations
• D801SP75031B1: Fluoroseal is a Light-Cured Cavity Liner used for Building the Cavity Floor in Deep Restorations
• D801SP75031: Fluoroseal is a Light-Cured Cavity Liner used for Building the Cavity Floor in Deep Restorations
• D801SP72036B1: Fluoroseal is a Light-Cured Cavity Liner used for Building the Cavity Floor in Deep Restorations