Empower Clear® 1475-18-230HD

GUDID 00190746141874

COSMETIC SL EMPOWER CLEAR INTERACT UL CUSPID 018 T=0 A+8 R=0 W/HK DIST

AMERICAN ORTHODONTICS CORPORATION

Self-ligating orthodontic bracket

• Primary Device ID: 00190746141874
• NIH Device Record Key: a0d09048-330a-4549-938c-502822d593df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Empower Clear®
• Version Model Number: 1475-18-230HD
• Catalog Number: 1475-18-230HD
• Company DUNS: 044668515
• Company Name: AMERICAN ORTHODONTICS CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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: 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	00190746141874 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122753

FDA Product Code

• NJM: Bracket, Ceramic, 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: 2019-01-28
• Device Publish Date: 2018-12-28

Devices Manufactured by AMERICAN ORTHODONTICS CORPORATION

• 00190746062803 - Buttons: 2024-07-26 DB BUTTON CIRCULAR BASE 10/PK
• 00190746062810 - Buttons: 2024-07-26 DB BUTTON CIRCULAR BASE 100/PK
• 00190746060755 - Buttons: 2024-07-09 DB BUTTON CIRCULAR BASE 10/PK
• 00190746060762 - Buttons: 2024-07-09 DB BUTTON CIRCULAR BASE 100/PK
• 00190746061554 - NT3: 2024-06-06 WIRE NITI FORM I LOWER 012 100/PK
• 00190746061561 - NT3: 2024-06-06 WIRE NITI FORM I LOWER 014 100/PK
• 00190746061578 - NT3: 2024-06-06 WIRE NITI FORM I LOWER 016X016 100/PK
• 00190746061592 - NT3: 2024-06-06 WIRE NITI FORM I LOWER 016X022 100/PK