OrthoMax® 905R

GUDID 00817645020016

OrthoMax® - Direct Bond 5g (Direct Bonding)

Six Month Smiles

Orthodontic bracket adhesive

• Primary Device ID: 00817645020016
• NIH Device Record Key: cb364af5-3d41-49c8-a3e0-9112fa68b43b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OrthoMax®
• Version Model Number: 905R
• Catalog Number: 905R
• 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	00817645020016 [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: 3
• Public Version Date: 2018-11-16
• Device Publish Date: 2016-09-24

On-Brand Devices [OrthoMax®]

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