Maximum Cure MCFSB

GUDID D798MCFSB0

Maximum Cure® Sealants are intended for use in direct and indirect bonding of brackets and appliances. This is the 7g bottle Part B. This is the Filled version.

RELIANCE ORTHODONTIC PRODUCTS INC

Dental composite resin

• Primary Device ID: D798MCFSB0
• NIH Device Record Key: ad850cca-7336-40c2-87d4-00a8eb92c25b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Maximum Cure
• Version Model Number: MCFSB
• Catalog Number: MCFSB
• 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	D798MCFSB0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K880791

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