Comp Plus "T"™ UL Bicuspid Roth .018 710-709T

GUDID 00842452100064

Upper Left Bicuspid .018 Roth Rx Direct Bond Composite Orthodontic Bracket

ORTHO SPECIALTIES

Orthodontic bracket, plastic, single-use

• Primary Device ID: 00842452100064
• NIH Device Record Key: 83549a06-f959-47d4-9f6e-1e72e14af469
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Comp Plus "T"™ UL Bicuspid Roth .018
• Version Model Number: 710-709T
• Catalog Number: 710-709T
• 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: true
• 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	00842452100064 [Primary]

FDA Product Code

• DYW: Bracket, Plastic, 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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

Devices Manufactured by ORTHO SPECIALTIES

• 00842452100491 - Adhere™ Light Cure Adhesive 5g Syringe: 2018-07-06 Light Cure Adhesive Paste In Syringe For Direct Bonding Orthodontic Brackets
• 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