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 Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material 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