Mini Master Series 126-031445

GUDID 00190746150289

1 PAT SETUP MINI MS 022 LOWER 5X5 W/HK 3,4,5 STICKY

AMERICAN ORTHODONTICS CORPORATION

Self-ligating orthodontic bracket

• Primary Device ID: 00190746150289
• NIH Device Record Key: eb6dc986-04ee-4637-972f-86035185e926
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mini Master Series
• Version Model Number: 126-031445
• Catalog Number: 126-031445
• 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: true
• 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: +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
• Phone: +1(800)558-7687
• Email: info@americanortho.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190746150289 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122753

FDA Product Code

• EJF: BRACKET, METAL, ORTHODONTIC
• 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: 2019-09-04
• Device Publish Date: 2019-08-27

On-Brand Devices [Mini Master Series]

• 00190746139734: TUBE FLANGELESS MINI MAND RIGHT 1ST MOLAR 022 CAST CONV T=0 A=0 R=0 3.5MM
• 00190746139727: TUBE FLANGELESS MINI MAND RIGHT 1ST MOLAR 018 CAST CONV T=0 A=0 R=0 3.5MM
• 00190746139710: TUBE FLANGELESS MINI MAND LEFT 1ST MOLAR 018 CAST CONV T=0 A=0 R=0 3.5MM W/HOOK
• 00190746139703: TUBE FLANGELESS MINI MAX LEFT 1ST MOLAR 022 CAST CONV T-14 A=0 R=10 3.5MM
• 00190746139697: TUBE FLANGELESS MINI MAX RIGHT 1ST MOLAR 022 CAST CONV T-14 A=0 R=10 3.5MM
• 00190746139680: TUBE FLANGELESS MINI MAX LEFT 1ST MOLAR 018 CAST CONV T-14 A=0 R=10 3.5MM
• 00190746139673: TUBE FLANGELESS MINI MAX RIGHT 1ST MOLAR 018 CAST CONV T-14 A=0 R=10 3.5MM
• 00190746139666: TUBE FLANGELESS MAX LEFT 1ST MOLAR 022 CAST CONV T-14 A=0 R=8 4.2MM W/HOOK
• 00190746139659: TUBE FLANGELESS MAX RIGHT 1ST MOLAR 022 CAST CONV T-14 A=0 R=8 4.2MM W/HOOK
• 00190746139642: TUBE FLANGELESS MAX LEFT 1ST MOLAR 018 CAST CONV T-14 A=0 R=8 4.2MM W/HOOK
• 00190746139635: TUBE FLANGELESS MAX RIGHT 1ST MOLAR 018 CAST CONV T-14 A=0 R=8 4.2MM W/HOOK
• 00190746139628: TUBE FLANGELESS MAND LEFT 1ST MOLAR 022 CAST CONV T25 A=0 R=8 4.2MM W/HOOK
• 00190746139611: TUBE FLANGELESS MAND RIGHT 1ST MOLAR 022 CAST CONV T25 A=0 R=8 4.2MM W/HOOK
• 00190746139604: TUBE FLANGELESS MAND LEFT 1ST MOLAR 018 CAST CONV T-25 A=0 R=8 4.2MM W/HOOK
• 00190746139598: TUBE FLANGELESS MINI MAX LEFT 1ST MOLAR 022 CAST CONV T-10 A=0 R=8 3.5MM
• 00190746139581: TUBE FLANGELESS MAX LEFT 1ST MOLAR 022 CAST CONV T-10 A=0 R=8 4.2MM W/HOOK
• 00190746139574: TUBE FLANGELESS MINI MAX RIGHT 1ST MOLAR 022 CAST CONV T-10 A=0 R=8 3.5MM
• 00190746139567: TUBE FLANGELESS MAX RIGHT 1ST MOLAR 022 CAST CONV T-10 A=0 R=8 4.2MM W/HOOK
• 00190746139550: TUBE FLANGELESS MAND RIGHT 1ST MOLAR 018 CAST CONV T-25 A=0 R=8 4.2MM W/HOOK
• 00190746139543: TUBE FLANGELESS MAND LEFT 1ST MOLAR 022 CAST CONV T-25 A=0 R=0 4.2MM W/HOOK
• 00190746139536: TUBE FLANGELESS MAND RIGHT 1ST MOLAR 022 CAST CONV T-25 A=0 R=0 4.2MM W/HOOK
• 00190746139529: TUBE FLANGELESS MAND LEFT 1ST MOLAR 018 CAST CONV T-25 A=0 R=0 4.2MM W/HOOK
• 00190746139512: TUBE FLANGELESS MAND RIGHT 1ST MOLAR 018 CAST CONV T-25 A=0 R=0 4.2MM W/HOOK
• 00190746139505: TUBE FLANGELESS MINI MAX LEFT 1ST MOLAR 018 CAST CONV T-10 A=0 R=8 3.5MM
• 00190746139499: TUBE FLANGELESS MAX LEFT 1ST MOLAR 018 CAST CONV T-10 A=0 R=8 4.2MM W/HOOK
• 00190746139482: TUBE FLANGELESS MINI MAX RIGHT 1ST MOLAR 018 CAST CONV T-10 A=0 R=8 3.5MM
• 00190746139475: TUBE FLANGELESS MAX RIGHT 1ST MOLAR 018 CAST CONV T-10 A=0 R=8 4.2MM W/HOOK
• 00190746139468: TUBE FLANGELESS MINI MAND LEFT 1ST MOLAR 022 CAST CONV T=0 A=0 R=8 3.5MM W/HOOK
• 00190746139451: TUBE FLANGELESS MINI MAND RIGHT 1ST MOLAR 022 CAST CONV T=0 A=0 R=8 3.5MM
• 00190746139444: TUBE FLANGELESS MINI MAND LEFT 1ST MOLAR 018 CAST CONV T=0 A=0 R=8 3.5MM W/HOOK
• 00190746139437: TUBE FLANGELESS MINI MAND RIGHT 1ST MOLAR 018 CAST CONV T=0 A=0 R=8 3.5MM
• 00190746139420: TUBE FLANGELESS MAND RIGHT 1ST MOLAR 022 CAST CONV T=0 A=0 R=0 4.2MM W/HOOK
• 00190746139413: TUBE FLANGELESS MINI MAND LEFT 1ST MOLAR 022 CAST CONV T=0 A=0 R=0 3.5MM W/HOOK
• 00190746139406: TUBE FLANGELESS MAND LEFT 1ST MOLAR 022 CAST CONV T=0 A=0 R=0 4.2MM W/HOOK
• 00190746139390: TUBE FLANGELESS MINI MAX LEFT 1ST MOLAR 022 CAST CONV T-10 A=0 R=0 3.5MM
• 00190746139383: TUBE FLANGELESS MAX LEFT 1ST MOLAR 022 CAST CONV T-10 A=0 R=0 4.2MM W/HOOK
• 00190746139376: TUBE FLANGELESS MINI MAX RIGHT 1ST MOLAR 022 CAST CONV T-10 A=0 R=0 3.5MM
• 00190746139369: TUBE FLANGELESS MAX RIGHT 1ST MOLAR 022 CAST CONV T-10 A=0 R=0 4.2MM W/HOOK
• 00190746139352: TUBE FLANGELESS MINI MAX LEFT 1ST MOLAR 018 CAST CONV T-10 A=0 R=0 3.5MM
• 00190746139345: TUBE FLANGELESS MAX LEFT 1ST MOLAR 018 CAST CONV T-10 A=0 R=0 4.2MM W/HOOK
• 00190746139338: TUBE FLANGELESS MINI MAX RIGHT 1ST MOLAR 018 CAST CONV T-10 A=0 R=0 3.5MM
• 00190746139321: TUBE FLANGELESS MAX RIGHT 1ST MOLAR 018 CAST CONV T-10 A=0 R=0 4.2MM W/HOOK
• 00190746139314: TUBE FLANGELESS MAND RIGHT 1ST MOLAR 018 CAST CONV T=0 A=0 R=0 4.2MM W/HOOK
• 00190746139307: TUBE FLANGELESS MAND LEFT 1ST MOLAR 018 CAST CONV T=0 A=0 R=0 4.2MM W/HOOK
• 00190746139291: TUBE FLANGELESS MINI MAND RIGHT 1ST MOLAR 018 CAST CONV T-25 A=0 R=0 3.5MM
• 00190746139284: TUBE FLANGELESS MINI MAND LEFT 1ST MOLAR 022 CAST CONV T-20 A=0 R=0 3.5MM
• 00190746139277: TUBE FLANGELESS MINI MAND RIGHT 1ST MOLAR 22 CAST CONV T-20 A=0 R=0 3.5MM
• 00190746139260: TUBE FLANGELESS MINI MAND LEFT 1ST MOLAR 018 CAST CONV T-20 A=0 R=0 3.5MM
• 00190746139253: TUBE FLANGELESS MINI MAND RIGHT 1ST MOLAR 018 CAST CONV T-20 A=0 R=0 3.5MM
• 00190746139246: TUBE FLANGELESS MINI MAND LEFT 1ST MOLAR 022 CAST CONV T-25 A=0 R=8 3.5MM