SciPharm Pit & Fissure Sealer Bonding Agent 54-011

GUDID D801SP54011B1

Self-Cured Resin for Sealing Occlusal Fissures and Bonding Composite Restoratives to Etched Enamel. Clear. Part A. Boxed

SCIENTIFIC PHARMACEUTICALS, INC.

Dental pit/fissure sealant

• Primary Device ID: D801SP54011B1
• NIH Device Record Key: 488e3d74-ffb6-4e7a-830f-c6dabe3ec8c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SciPharm Pit & Fissure Sealer Bonding Agent
• Version Model Number: SP 54-011 B
• Catalog Number: 54-011
• 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	D801SP54011B1 [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: 2016-08-05

On-Brand Devices [SciPharm Pit & Fissure Sealer Bonding Agent]

• D801SP5601S1: Light-Cured Resin for Sealing Occlusal Fissures and for Bonding Composite Restoratives to Etched
• D801SP5601CH1: Light-Cured Resin for Sealing Occlusal Fissures and for Bonding Composite Restoratives to Etched
• D801SP56011N1: Light-Cured Resin for Sealing Occlusal Fissures and for Bonding Composite Restoratives to Etched
• D801SP56011B1: Light-Cured Resin for Sealing Occlusal Fissures and for Bonding Composite Restoratives to Etched
• D801SP56011: Light-Cured Resin for Sealing Occlusal Fissures and for Bonding Composite Restoratives to Etched
• D801SP5401S1: Self-Cured Resin for Sealing Occlusal Fissures and Bonding Composite Restoratives to Etched Enam
• D801SP54011N1: Self-Cured Resin for Sealing Occlusal Fissures and Bonding Composite Restoratives to Etched Enam
• D801SP54011B1: Self-Cured Resin for Sealing Occlusal Fissures and Bonding Composite Restoratives to Etched Enam
• D801SP54011: Self-Cured Resin for Sealing Occlusal Fissures and Bonding Composite Restoratives to Etched Enam
• D801SP5301S1: Self-Cured Resin for Sealing Occlusal Fissures and Bonding Composite Restoratives to Etched Enam
• D801SP530111: Self-Cured Resin for Sealing Occlusal Fissures and Bonding Composite Restoratives to Etched Enam
• D801SP53011: Self-Cured Resin for Sealing Occlusal Fissures and Bonding Composite Restoratives to Etched Enam
• D801SP52091N1: Self-Curing Core Build-Up Restorative Paste/Paste Type. All Natural Shade. 50 grams. Part A.
• D801SP5201S1: Self-Cured Resin for Sealing Occlusal Fissures and Bonding Composite Restoratives to Etched Enam
• D801SP52012B1: Self-Cured Resin for Sealing Occlusal Fissures and Bonding Composite Restoratives to Etched Enam
• D801SP520121: Self-Cured Resin for Sealing Occlusal Fissures and Bonding Composite Restoratives to Etched Enam
• D801SP52011B1: Self-Cured Resin for Sealing Occlusal Fissures and Bonding Composite Restoratives to Etched Enam
• D801SP520111: Self-Cured Resin for Sealing Occlusal Fissures and Bonding Composite Restoratives to Etched Enam
• D801SP52011: Self-Cured Resin for Sealing Occlusal Fissures and Bonding Composite Restoratives to Etched Enam
• D801SP5101S1: Self-Cured Resin for Sealing Occlusal Fissures and Bonding Composite Restoratives to Etched Enam
• D801SP51011: Self-Cured Resin for Sealing Occlusal Fissures and Bonding Composite Restoratives to Etched Enam