SonicFill 3

GUDID 00841396185298

7/22/2018

Kerr Corporation

Dental composite resin

• Primary Device ID: 00841396185298
• NIH Device Record Key: ec3ab137-5203-404d-9f95-794d0080c4cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SonicFill 3
• Version Model Number: 36714
• 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: 8005377123
• Email: xxx@xxx.xxx
• Phone: 8005377123
• Email: xxx@xxx.xxx
• Phone: 8005377123
• Email: xxx@xxx.xxx
• Phone: 8005377123
• Email: xxx@xxx.xxx
• Phone: 8005377123
• Email: xxx@xxx.xxx
• Phone: 8005377123
• Email: xxx@xxx.xxx
• Phone: 8005377123
• Email: xxx@xxx.xxx
• Phone: 8005377123
• Email: xxx@xxx.xxx
• Phone: 8005377123
• Email: xxx@xxx.xxx
• Phone: 8005377123
• Email: xxx@xxx.xxx
• Phone: 8005377123
• Email: xxx@xxx.xxx
• Phone: 8005377123
• Email: xxx@xxx.xxx
• Phone: 8005377123
• Email: xxx@xxx.xxx
• Phone: 8005377123
• Email: xxx@xxx.xxx
• Phone: 8005377123
• Email: xxx@xxx.xxx
• Phone: 8005377123
• Email: xxx@xxx.xxx
• Phone: 8005377123
• Email: xxx@xxx.xxx
• Phone: 8005377123
• Email: xxx@xxx.xxx
• Phone: 8005377123
• Email: xxx@xxx.xxx
• Phone: 8005377123
• Email: xxx@xxx.xxx
• Phone: 8005377123
• Email: xxx@xxx.xxx
• Phone: 8005377123
• Email: xxx@xxx.xxx
• Phone: 8005377123
• Email: xxx@xxx.xxx
• Phone: 8005377123
• Email: xxx@xxx.xxx
• Phone: 8005377123
• Email: xxx@xxx.xxx
• Phone: 8005377123
• Email: xxx@xxx.xxx
• Phone: 8005377123
• Email: xxx@xxx.xxx
• Phone: 8005377123
• Email: xxx@xxx.xxx
• Phone: 8005377123
• Email: xxx@xxx.xxx
• Phone: 8005377123
• Email: xxx@xxx.xxx
• Phone: 8005377123
• Email: xxx@xxx.xxx
• Phone: 8005377123
• Email: xxx@xxx.xxx
• Phone: 8005377123
• Email: xxx@xxx.xxx
• Phone: 8005377123
• Email: xxx@xxx.xxx
• Phone: 8005377123
• Email: xxx@xxx.xxx
• Phone: 8005377123
• Email: xxx@xxx.xxx
• Phone: 8005377123
• Email: xxx@xxx.xxx
• Phone: 8005377123
• Email: xxx@xxx.xxx
• Phone: 8005377123
• Email: xxx@xxx.xxx
• Phone: 8005377123
• Email: xxx@xxx.xxx
• Phone: 8005377123
• Email: xxx@xxx.xxx
• Phone: 8005377123
• Email: xxx@xxx.xxx
• Phone: 8005377123
• Email: xxx@xxx.xxx
• Phone: 8005377123
• Email: xxx@xxx.xxx
• Phone: 8005377123
• Email: xxx@xxx.xxx
• Phone: 8005377123
• Email: xxx@xxx.xxx
• Phone: 8005377123
• Email: xxx@xxx.xxx
• Phone: 8005377123
• Email: xxx@xxx.xxx

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
• 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

• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841396185298 [Primary]
GS1	00841396194993 [Unit of Use]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-08-20
• Device Publish Date: 2018-07-18

On-Brand Devices [SonicFill 3]

• 00841396185304: Sonic-Activated, Single-Fill Composite; Intro Kit
• 00841396185298: 7/22/2018
• 00841396185281: Sonic-Activated, Single-Fill Composite; Unidose Refill; A3
• 00841396185274: Sonic-Activated, Single-Fill Composite; Unidose Refill; A2
• 00841396185267: Sonic-Activated, Single-Fill Composite; Unidose Refill; A1