SonicFill 2 36052

GUDID 10841396115926

SingleFill Composite System; Composite Material; Unidose; A2; Refill

Kerr Corporation

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• Primary Device ID: 10841396115926
• NIH Device Record Key: 598769ad-21eb-4004-84ab-bdd1a6a35862
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SonicFill 2
• Version Model Number: 36052
• Catalog Number: 36052
• Company DUNS: 199354556
• Company Name: Kerr Corporation
• Device Count: 20
• 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
• 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: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram

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
• 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	00841396115929 [Unit of Use]
GS1	10841396115926 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143209

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: 3
• Public Version Date: 2020-12-21
• Device Publish Date: 2016-08-01

On-Brand Devices [SonicFill 2]

• 10841396116404: Single-Fill Composite System; Intro Kit
• 10841396116398: Single-Fill Composite System; Value Kit
• 10841396115940: SingleFill Composite System; Composite Material; Unidose; B1; Refill
• 10841396115933: SingleFill Composite System; Composite Material; Unidose; A3; Refill
• 10841396115926: SingleFill Composite System; Composite Material; Unidose; A2; Refill
• 10841396115919: SingleFill Composite System; Composite Material; Unidose; A1; Refill