Empower 585-22-240HD

GUDID 00190746062841

DB BKT SL EMPOWER PASSIVE UL BICUSPID 022 T=0 A=0 R=0 W/HK DIST

AMERICAN ORTHODONTICS CORPORATION

Orthodontic bracket, metal

• Primary Device ID: 00190746062841
• NIH Device Record Key: d40abc55-9872-4607-ab8a-b89e692e2cae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Empower
• Version Model Number: 585-22-240HD
• Catalog Number: 585-22-240HD
• 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
• 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	00190746062841 [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: 2024-09-18
• Device Publish Date: 2024-09-10

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