Acid Etchant Gel Syringe Tip 020-028537

GUDID 00190746136870

ADHESIVE ACID ETCHANT GEL SYRINGE TIP 20/PK

AMERICAN ORTHODONTICS CORPORATION

Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution

• Primary Device ID: 00190746136870
• NIH Device Record Key: 3d99ab7d-a9fc-4f47-8ad2-47b904b60cd7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Acid Etchant Gel Syringe Tip
• Version Model Number: 020-028537
• Catalog Number: 020-028537
• 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	00190746136870 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K872569

FDA Product Code

• EBF: Material, Tooth Shade, Resin

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-10-15
• Device Publish Date: 2019-05-21

Devices Manufactured by AMERICAN ORTHODONTICS CORPORATION

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• 00190746061608 - NT3: 2024-06-06 WIRE NITI FORM I LOWER 016 100/PK
• 00190746061615 - NT3: 2024-06-06 WIRE NITI FORM I LOWER 017X025 100/PK
• 00190746061639 - NT3: 2024-06-06 WIRE NITI FORM I LOWER 018X018 100/PK
• 00190746061646 - NT3: 2024-06-06 WIRE NITI FORM I LOWER 018X025 100/PK