SciPharm Pit & Fissure Sealer Bonding Agent, White, Part A, NonBox 50-014

GUDID D801SP50014N1

Self-Cured Resin for Sealing Occusal Fissures and Bonding Composite Restoratives to Etched Enamel.

SCIENTIFIC PHARMACEUTICALS, INC.

Dental pit/fissure sealant

• Primary Device ID: D801SP50014N1
• NIH Device Record Key: 08f1ef16-4b6a-4b01-8422-2a82b1bd46e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SciPharm Pit & Fissure Sealer Bonding Agent, White, Part A, NonBox
• Version Model Number: SP 50-014 N
• Catalog Number: 50-014
• 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 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D801SP50014N1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K790788

FDA Product Code

• EBC: Sealant, Pit And Fissure, And Conditioner

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: 2016-07-07

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