SciPharm Cure-On Touch Orthodontic Adhesive 65-021

GUDID D801SP65021N1

Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Non-Boxed.

SCIENTIFIC PHARMACEUTICALS, INC.

Dentine adhesive

• Primary Device ID: D801SP65021N1
• NIH Device Record Key: 51454203-39a2-462b-aa8e-97a4c7e21275
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SciPharm Cure-On Touch Orthodontic Adhesive
• Version Model Number: SP 65-021 N
• Catalog Number: 65-021
• 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	D801SP65021N1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K791132

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

On-Brand Devices [SciPharm Cure-On Touch Orthodontic Adhesive]

• D801SP67028N1: Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix. Paste / Liquid
• D801SP67021: Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix. Paste / Liquid
• D801SP6602S1: Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix. Paste / Liquid
• D801SP66021: Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix. Paste / Liquid
• D801SP6512S1: Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Trial Syri
• D801SP65126B1: Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Activator
• D801SP651261: Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Activator
• D801SP65121N1: Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Activator
• D801SP65121B1: Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Activator
• D801SP65121: Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Trial Syri
• D801SP6502S1: Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Spanish.
• D801SP65028C1: Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Part B. C
• D801SP65024B1: Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Part B. B
• D801SP650241: Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Part B. N
• D801SP65023SB1: Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. 9 gram Lig
• D801SP65023B1: Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. 9 gram Lig
• D801SP650231: Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. 9 gram Lig
• D801SP65022B1: Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Part B. B
• D801SP650221: Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Part B. B
• D801SP65021N1: Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Non-Boxed.
• D801SP65021B1: Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Boxed.
• D801SP65021: Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar.