Locktight™ Auto Mix Band Cement Natural 600-401

GUDID 00842452100590

Glass Ionomer Cement For Orthodontic Bands-Natural Color

ORTHO SPECIALTIES

Orthodontic bracket adhesive

• Primary Device ID: 00842452100590
• NIH Device Record Key: 67130e13-6225-4ad6-9b4d-1933d1792642
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Locktight™ Auto Mix Band Cement Natural
• Version Model Number: 600-401
• Catalog Number: 600-401
• Company DUNS: 011050583
• Company Name: ORTHO SPECIALTIES
• 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: 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: 800-637-1237
• Email: contactus@orthospecialties.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842452100590 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012673

FDA Product Code

• EBF: Material, Tooth Shade, 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: 2016-09-24

Devices Manufactured by ORTHO SPECIALTIES

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• 00842452100507 - Adhere™ Light Cure Adhesive Kit: 2018-07-06 Light Cure Adhesive Kit For Direct Bonding Orthodontic Brackets
• 00842452100514 - Adhere™ Light Cure Adhesive Tips: 2018-07-06 Light Cure Adhesive Preloaded Tips For Direct Bonding Orthodontic Brackets
• 00842452100521 - Adhere™ Light Cure Adhesive Primer: 2018-07-06 Light Cure Adhesive Primer For Direct Bonding Orthodontic Brackets
• 00842452100538 - Adhere™ Enamel Etch Conditioner: 2018-07-06 Phosphoric Acid Etch For Direct Bonding Orthodontic Brackets
• 00842452100545 - Adhere™ Self Cure Adhesive Kit: 2018-07-06 Self Curing Adhesive Kit For Direct Bonding Orthodontic Brackets
• 00842452100552 - Adhere™ Self Cure Adhesive Tips: 2018-07-06 Self Curing Adhesive Preloaded Tips For Direct Bonding Orthodontic Brackets
• 00842452100569 - Adhere™ Self Cure Activator: 2018-07-06 Self Curing Adhesive Primer For Direct Bonding Orthodontic Brackets