SciPharm Seal and Bond Orthodontic 60-024

GUDID D801SP600241

Applied as an intermediate between enamel or dentin and as a restorative material or cement.

SCIENTIFIC PHARMACEUTICALS, INC.

Dentine adhesive Dentine adhesive

• Primary Device ID: D801SP600241
• NIH Device Record Key: 3e4a4f55-87dd-483b-9a18-3f75d7d6bf5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SciPharm Seal and Bond Orthodontic
• Version Model Number: SP 60-024
• Catalog Number: 60-024
• 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	D801SP600241 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K790962

FDA Product Code

• DYH: Adhesive, Bracket And Tooth Conditioner, Resin

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

Devices Manufactured by SCIENTIFIC PHARMACEUTICALS, INC.

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• D801SP70221 - DFV Desensitizing Varnish (Wonderful Varnish) Spearmint: 2022-01-27 DFV Desensitizing Varnish (Wonderful Varnish), Spearmint flavor, is a fluoride-containing resin preparation for the treatment of
• D801SP70231 - DFV Desensitizing Varnish (Wonderful Varnish) Chocolate: 2022-01-27 DFV Desensitizing Varnish (Wonderful Varnish), Chocolate flavor, is a fluoride-containing resin preparation for the treatment of
• D801SP70241 - DFV Desensitizing Varnish (Wonderful Varnish) Marshmallow: 2022-01-27 DFV Desensitizing Varnish (Wonderful Varnish), Marshmallow flavor, is a fluoride-containing resin preparation for the treatment
• D801SP70201 - DFV Desensitizing Varnish (Wonderful Varnish) Strawberry: 2021-08-16 DFV Desensitizing Varnish (Wonderful Varnish), Strawberry flavor, is a fluoride-containing resin preparation for the treatment
• D801AV44001 - Improv Temporary Implant Cement by Dentegris Dental Implant System: 2020-12-21 Improv - A Resin-Based Provisional Luting Agent Designed for Temporary Cementation of Implants and Conventional Crown and Bridge
• D801IMPROVECEMENT1 - Improv Temporary Implant Cement by Salvin Dental Specialties: 2020-12-21 Improv - A Resin-Based Provisional Luting Agent Designed for Temporary Cementation of Implants and Conventional Crown and Bridge
• D80150041 - SciPharm Anterior/Posterior Composite Resin Paste/Paste: 2018-07-06 Anterior/Posterior Resin Based Restorative Material