PowerBar 855-027

GUDID 00190746164910

FIXED FUNCT POWERBAR CLASS II 27MM UNIV 2/PK

AMERICAN ORTHODONTICS CORPORATION

Orthodontic rod-based aligner

• Primary Device ID: 00190746164910
• NIH Device Record Key: 166ac8ac-4db0-4772-8188-63d335af8545
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PowerBar
• Version Model Number: 855-027
• Catalog Number: 855-027
• Company DUNS: 044668515
• Company Name: AMERICAN ORTHODONTICS CORPORATION
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• 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: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190746164910 [Primary]

FDA Product Code

• DYJ: RETAINER, SCREW EXPANSION, 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: 2025-01-03
• Device Publish Date: 2023-01-23

On-Brand Devices [PowerBar]

• 00190746164910: FIXED FUNCT POWERBAR CLASS II 27MM UNIV 2/PK
• 00190746164903: FIXED FUNCT POWERBAR CLASS II 26MM UNIV 2/PK
• 00190746164897: FIXED FUNCT POWERBAR CLASS II 25MM UNIV 2/PK