SonicFill 3

GUDID 00841396185304

Sonic-Activated, Single-Fill Composite; Intro Kit

Kerr Corporation

Dental composite resin

• Primary Device ID: 00841396185304
• NIH Device Record Key: b037fb3b-0156-49c5-938e-495e6a09fee6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SonicFill 3
• Version Model Number: 36710
• Company DUNS: 199354556
• Company Name: Kerr Corporation
• Device Count: 66
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: 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: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841396185304 [Primary]
GS1	00841396194979 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143209

FDA Product Code

• EBC: Sealant, Pit And Fissure, And Conditioner

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00841396185304]

Moist Heat or Steam Sterilization

[00841396185304]

Moist Heat or Steam Sterilization

[00841396185304]

Moist Heat or Steam Sterilization

[00841396185304]

Moist Heat or Steam Sterilization

[00841396185304]

Moist Heat or Steam Sterilization

[00841396185304]

Moist Heat or Steam Sterilization

[00841396185304]

Moist Heat or Steam Sterilization

[00841396185304]

Moist Heat or Steam Sterilization

[00841396185304]

Moist Heat or Steam Sterilization

[00841396185304]

Moist Heat or Steam Sterilization

[00841396185304]

Moist Heat or Steam Sterilization

[00841396185304]

Moist Heat or Steam Sterilization

[00841396185304]

Moist Heat or Steam Sterilization

[00841396185304]

Moist Heat or Steam Sterilization

[00841396185304]

Moist Heat or Steam Sterilization

[00841396185304]

Moist Heat or Steam Sterilization

[00841396185304]

Moist Heat or Steam Sterilization

[00841396185304]

Moist Heat or Steam Sterilization

[00841396185304]

Moist Heat or Steam Sterilization

[00841396185304]

Moist Heat or Steam Sterilization

[00841396185304]

Moist Heat or Steam Sterilization

[00841396185304]

Moist Heat or Steam Sterilization

[00841396185304]

Moist Heat or Steam Sterilization

[00841396185304]

Moist Heat or Steam Sterilization

[00841396185304]

Moist Heat or Steam Sterilization

[00841396185304]

Moist Heat or Steam Sterilization

[00841396185304]

Moist Heat or Steam Sterilization

[00841396185304]

Moist Heat or Steam Sterilization

[00841396185304]

Moist Heat or Steam Sterilization

[00841396185304]

Moist Heat or Steam Sterilization

[00841396185304]

Moist Heat or Steam Sterilization

[00841396185304]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-08-27
• Device Publish Date: 2018-07-27

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