SciPharm Copal Cavity Varnish 1

GUDID D801SP7002B1

Copal Cavity Varnish was formulated to protect dentin from acids released by filling materials. Provides a chemical and thermal barrier while eliminating air pockets. Thinner Bottle. Boxed.

SCIENTIFIC PHARMACEUTICALS, INC.

Dental cavity varnish

• Primary Device ID: D801SP7002B1
• NIH Device Record Key: 12b00778-ea95-4916-9f15-b9af08f0b916
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SciPharm Copal Cavity Varnish
• Version Model Number: SP 70-02 B
• Catalog Number: 1
• 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	D801SP7002B1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K800438

FDA Product Code

• LBH: Varnish, Cavity

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: 2016-08-10

On-Brand Devices [SciPharm Copal Cavity Varnish]

• D801SP7103N1: Universal Copal Cavity Varnish was formulated to protect dentin from acids released by filling m
• D801SP71031: Universal Copal Cavity Varnish was formulated to protect dentin from acids released by filling m
• D801SP70041: Universal Copal Cavity Varnish was formulated to protect dentin from acids released by filling m
• D801SP7003SB1: Universal Copal Cavity Varnish was formulated to protect dentin from acids released by filling m
• D801SP7003N1: Universal Copal Cavity Varnish was formulated to protect dentin from acids released by filling m
• D801SP7003B1: Universal Copal Cavity Varnish was formulated to protect dentin from acids released by filling m
• D801SP7002B1: Copal Cavity Varnish was formulated to protect dentin from acids released by filling materials.
• D801SP70021: Copal Cavity Varnish was formulated to protect dentin from acids released by filling materials.
• D801SP7001SB1: Copal Cavity Varnish was formulated to protect dentin from acids released by filling materials.
• D801SP7001N1: Copal Cavity Varnish was formulated to protect dentin from acids released by filling materials.
• D801SP7001B1: Copal Cavity Varnish was formulated to protect dentin from acids released by filling materials.