OrthoMax® 06R

GUDID 00817645020160

OrthoMax® - Direct Bond 5g (Non Flouride)

Six Month Smiles

Orthodontic bracket adhesive

• Primary Device ID: 00817645020160
• NIH Device Record Key: a8f416cf-dd46-4476-b1d1-7ee0521f98e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OrthoMax®
• Version Model Number: 906R
• Catalog Number: 06R
• Company DUNS: 081365847
• Company Name: Six Month Smiles
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817645020160 [Primary]

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: 2
• Public Version Date: 2018-11-16
• Device Publish Date: 2018-07-30

On-Brand Devices [OrthoMax®]

• 00817645020160: OrthoMax® - Direct Bond 5g (Non Flouride)
• 00817645020016: OrthoMax® - Direct Bond 5g (Direct Bonding)