SciPharm Fastil Saliva-Cured Temporary Restorative 55-601

GUDID D801SP55601BSN1

Fastfil - A Saliva-Cured Temporary Restorative Jar. Non-Boxed. Spanish

SCIENTIFIC PHARMACEUTICALS, INC.

Dental composite resin

• Primary Device ID: D801SP55601BSN1
• NIH Device Record Key: 8b2c9c62-2093-48ac-89c8-1f4e4542f787
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SciPharm Fastil Saliva-Cured Temporary Restorative
• Version Model Number: SP 55-601 BSN
• Catalog Number: 55-601
• 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 15 Degrees Fahrenheit and 83 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Fahrenheit and 83 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D801SP55601BSN1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K934184

FDA Product Code

• EMA: Cement, Dental

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 Fastil Saliva-Cured Temporary Restorative]

• D801SP55602T1: Fastfil - A Saliva-Cured Temporary Restorative Tube.
• D801SP55601BSN1: Fastfil - A Saliva-Cured Temporary Restorative Jar. Non-Boxed. Spanish
• D801SP55601BS1: Fastfil - A Saliva-Cured Temporary Restorative. Boxed. Spanish.
• D801SP55601B1: Fastfil - A Saliva-Cured Temporary Restorative. Boxed.
• D801SP556011: Fastfil - A Saliva-Cured Temporary Restorative.