ImpressaSure 861-137

GUDID 00190746008146

SUPPLIES-IMPRESSA/SURE PVS SUHY LIGHT WASH SYRINGE W/18 MIX TIPS KIT

AMERICAN ORTHODONTICS CORPORATION

Alginate dental impression material

• Primary Device ID: 00190746008146
• NIH Device Record Key: 1495cfe2-3d69-4332-91c6-e5cc4e382fa1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ImpressaSure
• Version Model Number: 861-137
• Catalog Number: 861-137
• 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: 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
• 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
• 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
• 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
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• 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 25 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190746008146 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K963205

FDA Product Code

• ELW: MATERIAL, IMPRESSION

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-08

On-Brand Devices [ImpressaSure]

• 00190746008146: SUPPLIES-IMPRESSA/SURE PVS SUHY LIGHT WASH SYRINGE W/18 MIX TIPS KIT
• 00190746008139: SUPPLIES-IMPRESSA/SURE PVS SUHY PUTTY A&B KIT