Empower 126-038619

GUDID 00190746061523

1 PAT SETUP SL EMPOWER DUAL ACT 128 022 U/L 5X5 W/HK 3,4,5 STICKY BX

AMERICAN ORTHODONTICS CORPORATION

Orthodontic bracket, metal

• Primary Device ID: 00190746061523
• NIH Device Record Key: 0cf769d9-9cc0-4759-b678-8c1d1bb99036
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Empower
• Version Model Number: 126-038619
• Catalog Number: 126-038619
• Company DUNS: 044668515
• Company Name: AMERICAN ORTHODONTICS CORPORATION
• 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: true
• 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
• 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	00190746061523 [Primary]

FDA Product Code

• EJF: BRACKET, METAL, 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: 2024-03-29
• Device Publish Date: 2024-03-21

On-Brand Devices [Empower]

• 00190746061530: 1 PAT SETUP SL EMPOWER DUAL ACT 128 022 U/L 5X5 W/HK 3 STICKY BX
• 00190746061523: 1 PAT SETUP SL EMPOWER DUAL ACT 128 022 U/L 5X5 W/HK 3,4,5 STICKY BX
• 00190746062841: DB BKT SL EMPOWER PASSIVE UL BICUSPID 022 T=0 A=0 R=0 W/HK DIST
• 00190746062827: DB BKT SL EMPOWER PASSIVE UR BICUSPID 022 T=0 A=0 R=0 W/HK DIST