Shatkin FIRST Resin Cement Self-Cure SFRC

GUDID D801SFRCB1

Shatkin First - An Advanced Eugenol Free Solution for Permanent Crown and Bridge Cementation. Resin Adhesive. 6-gram Dual Barrel. Boxed.

SCIENTIFIC PHARMACEUTICALS, INC.

Glass ionomer dental cement Glass ionomer dental cement

• Primary Device ID: D801SFRCB1
• NIH Device Record Key: c3870352-06bf-4ac3-9851-875adcf1f90b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shatkin FIRST Resin Cement Self-Cure
• Version Model Number: SFRC
• Catalog Number: SFRC
• 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: 18006343047
• Email: Denise@scipharm.com
• Phone: 18006343047
• Email: Denise@scipharm.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D801SFRCB1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K823935

FDA Product Code

• EMA: Cement, Dental

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-05

On-Brand Devices [Shatkin FIRST Resin Cement Self-Cure]

• D801SFRCB1: Shatkin First - An Advanced Eugenol Free Solution for Permanent Crown and Bridge Cementation. R
• D801SFRC1: Shatkin First - An Advanced Eugenol Free Solution to Temporary Crown and Bridge Cementation. Re