Maximum Cure MC7AF

GUDID D798MC7AF0

Maximum Cure® Sealants are intended for use in direct and indirect bonding of brackets and appliances. This is the 7g Maximum Cure Part A with Fluoride. Product contains fluoride

RELIANCE ORTHODONTIC PRODUCTS INC

Dental composite resin Dental composite resin

• Primary Device ID: D798MC7AF0
• NIH Device Record Key: 0de8b880-7108-4388-9d9f-e668454ad811
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Maximum Cure
• Version Model Number: MC7AF
• Catalog Number: MC7AF
• Company DUNS: 113170088
• Company Name: RELIANCE ORTHODONTIC PRODUCTS 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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: 630-773-4009
• Email: paulgropi@aol.com
• Phone: 630-773-4009
• Email: paulgropi@aol.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store refrigerated (2-8 Degrees C) Avoid excessive heat. Allow to reach room temperature prior to use.
• Special Storage Condition, Specify: Between 0 and 0 *Store refrigerated (2-8 Degrees C) Avoid excessive heat. Allow to reach room temperature prior to use.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D798MC7AF0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K894566

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: 2016-08-06

On-Brand Devices [Maximum Cure ]

• D798MCFSB0: Maximum Cure® Sealants are intended for use in direct and indirect bonding of brackets and appl
• D798MCF7AF0: Maximum Cure® Sealants are intended for use in direct and indirect bonding of brackets and appl
• D798MC7B0: Maximum Cure® Sealants are intended for use in direct and indirect bonding of brackets and appl
• D798MC7AF0: Maximum Cure® Sealants are intended for use in direct and indirect bonding of brackets and appl
• D798MC20B0: Maximum Cure® Sealants are intended for use in direct and indirect bonding of brackets and appl
• D798MC20AF0: Maximum Cure® Sealants are intended for use in direct and indirect bonding of brackets and appl