SonicFill 3

GUDID 00841396185298

7/22/2018

Kerr Corporation

Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin 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