Sci-Pharm Pit & Fissure Sealer 50-01

GUDID D801SP50011

Self-Cured Resin for sealing occlusal fissures and bonding composite restoratives to etched enamel

SCIENTIFIC PHARMACEUTICALS, INC.

Dental pit/fissure sealant

• Primary Device ID: D801SP50011
• NIH Device Record Key: fb6fc5f9-3f25-4076-bc67-dd7a61695f50
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sci-Pharm Pit & Fissure Sealer
• Version Model Number: SP 50-01
• Catalog Number: 50-01
• 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: 909-595-9922
• Email: Denise@scipharm.com
• Phone: 909-595-9922
• 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	D801SP50011 [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: 2016-06-02

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