MR Lock LC 001-975

GUDID 00190746007880

MR LOCK BAND CEMENT KIT

AMERICAN ORTHODONTICS CORPORATION

Orthodontic bracket adhesive

• Primary Device ID: 00190746007880
• NIH Device Record Key: 94449dd4-7eec-47d4-aa9e-262448494556
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MR Lock LC
• Version Model Number: 001-975
• Catalog Number: 001-975
• Company DUNS: 044668515
• Company Name: AMERICAN ORTHODONTICS CORPORATION
• 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: true
• Device Combination Product: false
• Single Use: true
• 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: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190746007880 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001446

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: 2016-11-09

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