PowerScope 852-016538

GUDID 00190746202742

FIXED FUNCT POWERSCOPE 5/KIT

AMERICAN ORTHODONTICS CORPORATION

Orthodontic rod-based aligner

• Primary Device ID: 00190746202742
• NIH Device Record Key: 052f78d9-5ff8-4788-8589-3810b5ef0635
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PowerScope
• Version Model Number: 852-016538
• Catalog Number: 852-016538
• Company DUNS: 044668515
• Company Name: AMERICAN ORTHODONTICS CORPORATION
• Device Count: 1
• DM Exempt: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190746202742 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-04-01
• Device Publish Date: 2026-03-24

On-Brand Devices [PowerScope]

• 00190746202759: FIXED FUNCT POWERSCOPE 1/KIT
• 00190746202742: FIXED FUNCT POWERSCOPE 5/KIT
• 00190746153273: FIXED FUNCT POWERSCOPE ATTACHMENT NUTS 5 RIGHT AND 5 LEFT
• 00190746067587: FIXED FUNCT POWERSCOPE ALT ATTACHMENT NUTS 5 RIGHT AND 5 LEFT
• 00190746067563: FIXED FUNCT POWERSCOPE LEFT MECHANISM
• 00190746067549: FIXED FUNCT POWERSCOPE RIGHT MECHANISM