SciPharm Fluoroseal Cavity Liner 75-035

GUDID D801SP75035B1

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. Boxed.

SCIENTIFIC PHARMACEUTICALS, INC.

Dental cavity varnish

• Primary Device ID: D801SP75035B1
• NIH Device Record Key: 5107b68e-385e-4afe-85a6-497ca17dd2a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SciPharm Fluoroseal Cavity Liner
• Version Model Number: SP 75-035 B
• Catalog Number: 75-035
• 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	D801SP75035B1 [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