Multi-Adjustable Facemask 600-524

GUDID 00842452100606

Adjustable Reverse Pull Headgear With Center Bar For Class III Treatment

ORTHO SPECIALTIES

Orthodontic extraoral headgear

• Primary Device ID: 00842452100606
• NIH Device Record Key: 97a612e8-2082-4f97-9497-0216652a72f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Multi-Adjustable Facemask
• Version Model Number: 600-524
• Catalog Number: 600-524
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842452100606 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000358

FDA Product Code

• DZB: Headgear, Extraoral, Orthodontic

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

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• 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