Acid Etching 001-903

GUDID 00190746007804

ETCHING SOLUTION SEMI GEL 9 GMS

AMERICAN ORTHODONTICS CORPORATION

Dental etching solution

• Primary Device ID: 00190746007804
• NIH Device Record Key: eee4ece6-bc5a-49af-94c8-e5c191b7e5c8
• Commercial Distribution Discontinuation: 2019-07-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Acid Etching
• Version Model Number: 001-903
• Catalog Number: 001-903
• 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: true
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190746007804 [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: 4
• Public Version Date: 2019-07-02
• Device Publish Date: 2016-11-09

On-Brand Devices [Acid Etching]

• 00190746007828: ETCHING SOLUTION GEL 12 GM SYRINGE & TIPS
• 00190746007811: ETCHING SOLUTION LIQUID 14 CC
• 00190746007804: ETCHING SOLUTION SEMI GEL 9 GMS