Tytin FC

GUDID 10841396117807

Self-Activating Capsule - Fast Set - Firm Packing Dental Amalgam - Single Spill

KERR CORPORATION

Dental amalgam alloy

• Primary Device ID: 10841396117807
• NIH Device Record Key: 9e324d9b-5132-4020-bb44-14431febe1c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tytin FC
• Version Model Number: 29990
• Company DUNS: 847905890
• Company Name: KERR CORPORATION
• Device Count: 50
• 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: +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

• Weight: 400 Milligram
• Weight: 400 Milligram
• Weight: 400 Milligram
• Weight: 400 Milligram
• Weight: 400 Milligram
• Weight: 400 Milligram
• Weight: 400 Milligram
• Weight: 400 Milligram
• Weight: 400 Milligram
• Weight: 400 Milligram
• Weight: 400 Milligram
• Weight: 400 Milligram
• Weight: 400 Milligram
• Weight: 400 Milligram
• Weight: 400 Milligram
• Weight: 400 Milligram
• Weight: 400 Milligram

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool well-ventilated place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool well-ventilated place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool well-ventilated place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool well-ventilated place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool well-ventilated place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool well-ventilated place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool well-ventilated place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool well-ventilated place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool well-ventilated place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool well-ventilated place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool well-ventilated place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool well-ventilated place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool well-ventilated place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool well-ventilated place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool well-ventilated place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool well-ventilated place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool well-ventilated place

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841396117800 [Unit of Use]
GS1	10841396117807 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K951663

FDA Product Code

• EJJ: Alloy, amalgam

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 [Tytin FC]

• 10841396117852: Self-Activating Capsule - Fast Set - Firm Packing Dental Amalgam - Triple Spill
• 10841396117838: Self-Activating Capsule - Fast Set - Firm Packing Dental Amalgam - Double Spill
• 10841396117821: Self-Activating Capsule - Fast Set - Firm Packing Dental Amalgam - Double Spill
• 10841396117814: Self-Activating Capsule - Fast Set - Firm Packing Dental Amalgam - Single Spill
• 10841396117807: Self-Activating Capsule - Fast Set - Firm Packing Dental Amalgam - Single Spill
• 10841396117791: Self-Activating Capsule - Regular Set - Firm Packing Dental Amalgam - Triple Spill
• 10841396117753: Self-Activating Capsule - Regular Set - Firm Packing Dental Amalgam - Single Spill
• 10841396117746: Self-Activating Capsule - Regular Set - Firm Packing Dental Amalgam - Single Spill