Take 1 Advanced

GUDID 10841396118118

Impression Material - Light Body Wash - Fast Set - 2 Cartridges (50 ml each)

KERR CORPORATION

Silicone dental impression material

• Primary Device ID: 10841396118118
• NIH Device Record Key: a26e1fce-3acb-4c8f-8611-ec4062cfe3fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Take 1 Advanced
• Version Model Number: 33953
• Company DUNS: 847905890
• Company Name: KERR CORPORATION
• Device Count: 2
• 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: false
• 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: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com

Device Dimensions

• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at ambient temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at ambient temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at ambient temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at ambient temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at ambient temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at ambient temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at ambient temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at ambient temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at ambient temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at ambient temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at ambient temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at ambient temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at ambient temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at ambient temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at ambient temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at ambient temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at ambient temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841396118111 [Unit of Use]
GS1	10841396118118 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091613

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: 4
• Public Version Date: 2020-03-16
• Device Publish Date: 2016-08-31

On-Brand Devices [Take 1 Advanced]

• 10841396118576: Value Pack - Impression Material - Rigid Tray - Super Fast Set - 24 Cartridges (50 ml each)
• 10841396118569: Value Pack - Impression Material - Rigid Tray - Fast Set - 24 Cartridges (50 ml each)
• 10841396118552: Volume - Impression Material - Rigid Tray - Super Fast Set - 2 Hard Cartridges (380 ml each)
• 10841396118545: Volume - Impression Material - Rigid Tray - Fast Set - 2 Hard Cartridges (380 ml each)
• 10841396118538: Volume - Impression Material - Tray - Super Fast Set - 2 Hard Cartridges (380 ml each)
• 10841396118521: Volume - Impression Material - Tray - Fast Set - 2 Hard Cartridges (380 ml each)
• 10841396118514: Volume - Impression Material - Tray - Regular Set - 2 Hard Cartridges (380 ml each)
• 10841396118507: Volume - Impression Material - Medium/ MoNophase - Super Fast Set - 2 Hard Cartridges (380 ml ea
• 10841396118491: Volume - Impression Material - Medium/ MoNophase - Fast Set - 2 Hard Cartridges (380 ml each)
• 10841396118484: Volume - Impression Material - Medium/ MoNophase - Regular Set - 2 Hard Cartridges (380 ml each)
• 10841396118439: Impression Material - Rigid Tray - Super Fast Set - 2 Cartridges (50 ml each)
• 10841396118422: Impression Material - Rigid Tray - Fast Set - 2 Cartridges (50 ml each)
• 10841396118392: Unidose Refill - Impression Material - Regular Body Wash - Super Fast Set - 20 Syringes (2 ml ea
• 10841396118385: Unidose Refill - Impression Material - Regular Body Wash - Fast Set - 20 Syringes (2 ml each)
• 10841396118378: Unidose Refill - Impression Material - Regular Body Wash - Regular Set - 20 Syringes (2 ml each)
• 10841396118361: Unidose Refill - Impression Material - Light Body Wash - Super Fast Set - 20 Syringes (2 ml each
• 10841396118354: Unidose Refill - Impression Material - Light Body Wash - Fast Set - 20 Syringes (2 ml each)
• 10841396118347: Unidose Refill - Impression Material - Light Body Wash - Regular Set - 20 Syringes (2 ml each)
• 10841396118330: Impression Material - Bite Registration - 2 Cartridges (50 ml each)
• 10841396118323: Value Pack - Impression Material - Regular Body Wash - Super Fast Set - 24 Cartridges (50 ml eac
• 10841396118316: Impression Material - Regular Body Wash - Super Fast Set - 2 Cartridges (50 ml each)
• 10841396118309: Value Pack - Impression Material - Regular Body Wash - Fast Set - 24 Cartridges (50 ml each)
• 10841396118293: Impression Material - Regular Body Wash - Fast Set - 2 Cartridges (50 ml each)
• 10841396118286: Value Pack - Impression Material - Regular Body Wash - Regular Set - 24 Cartridges (50 ml each)
• 10841396118279: Impression Material - Regular Body Wash - Regular Set - 2 Cartridges (50 ml each)
• 10841396118262: Value Pack - Impression Material - Tray - Super Fast Set - 24 Cartridges (50 ml each)
• 10841396118255: Impression Material - Tray - Super Fast Set - 2 Cartridges (50 ml each)
• 10841396118248: Value Pack - Impression Material - Tray - Fast Set - 24 Cartridges (50 ml each)
• 10841396118231: Impression Material - Tray - Fast Set - 2 Cartridges (50 ml each)
• 10841396118224: Value Pack - Impression Material - Tray - Regular Set - 24 Cartridges (50 ml each)
• 10841396118217: Impression Material - Tray - Regular Set - 2 Cartridges (50 ml each)
• 10841396118200: Value Pack - Impression Material - Medium/ MoNophase - Super Fast Set - 24 Cartridges (50 ml eac
• 10841396118194: Impression Material - Medium/ MoNophase - Super Fast Set - 2 Cartridges (50 ml each)
• 10841396118187: Value Pack - Impression Material - Medium/ MoNophase - Fast Set - 24 Cartridges (50 ml each)
• 10841396118170: Impression Material - Medium/ MoNophase - Fast Set - 2 Cartridges (50 ml each)
• 10841396118163: Value Pack - Impression Material - Medium/ MoNophase - Regular Set - 24 Cartridges (50 ml each)
• 10841396118156: Impression Material - Medium/ MoNophase - Regular Set - 2 Cartridges (50 ml each)
• 10841396118149: Value Pack - Impression Material - Light Body Wash - Super Fast Set - 24 Cartridges (50 ml each)
• 10841396118132: Impression Material - Light Body Wash - Super Fast Set - 2 Cartridges (50 ml each)
• 10841396118125: Value Pack - Impression Material - Light Body Wash - Fast Set - 24 Cartridges (50 ml each)
• 10841396118118: Impression Material - Light Body Wash - Fast Set - 2 Cartridges (50 ml each)
• 10841396118101: Value Pack - Impression Material - Light Body Wash - Regular Set - 24 Cartridges (50 ml each)
• 10841396118095: Impression Material - Light Body Wash - Regular Set - 2 Cartridges (50 ml each)
• 10841396112871: Impression Material - Product Sample - Regular Body - Tray - Regular Set
• 10841396112864: Impression Material - Product Sample - Light Body - Tray - Super Fast Set
• 10841396112857: Impression Material - Product Sample - Light Body - Rigid Tray - Super Fast Set
• 10841396112840: Impression Material - Product Sample - Light Body - Rigid Tray - Fast Set
• 10841396112826: Impression Material - Product Sample - Regular Body - Tray - Super Fast Set
• 10841396102797: Impression Material - Product Sample - Light Body - Tray - Regular Set - 2 Cartridges (50 ml eac
• 10841396102476: Impression Material - Product Sample - Regular Body - Tray - Fast Set - 2 Cartridges (50 ml each