NX3 33643

GUDID 00841396100079

Nexus Third Generation; Dual-Cure Resin Cement; Automix Dual-Cure Syringe; Clear; Refill

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

• Primary Device ID: 00841396100079
• NIH Device Record Key: 32e2e85b-8d60-4400-88a2-629089289cdb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NX3
• Version Model Number: 33643
• Catalog Number: 33643
• Company DUNS: 199354556
• Company Name: Kerr Corporation
• Device Count: 1
• 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: 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: +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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at ambient temperature
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841396100079 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013609

FDA Product Code

• EMA: CEMENT, DENTAL

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: 2018-07-06
• Device Publish Date: 2016-09-12

On-Brand Devices [NX3]

• 00841396116285: Nexus Third Generation; Universal Adhesive Resin Cement; Intro Kit
• 00841396108266: Third Generation; Universal Adhesive Resin Cement; Trial Kit
• 00841396108099: NX3 Nexus Third Generation & OptiBond XTR
• 00841396108082: Nexus Third Generation; Universal Adhesive Resin Cement; Light-Cure Kit
• 00841396108075: Nexus Third Generation; Universal Adhesive Resin Cement; Intro Kit with Risk-Free Trial Kit
• 00841396105166: Try-In Gel; Syringe; Bleach; Refill
• 00841396105159: Try-In Gel; Syringe; White Opaque; Refill
• 00841396105142: Try-In Gel; Syringe; Yellow; Refill
• 00841396105135: Try-In Gel; Syringe; White; Refill
• 00841396105128: Try-In Gel; Syringe; Clear; Refill
• 00841396105104: Nexus Third Generation; Light Cure Resin Cement; Light-Cure Syringe; White Opaque; Refill
• 00841396105098: Nexus Third Generation; Light Cure Resin Cement; Light-Cure Syringe; Bleach; Refill
• 00841396105081: Nexus Third Generation; Light Cure Resin Cement; Light-Cure Syringe; Yellow; Refill
• 00841396105074: Nexus Third Generation; Light Cure Resin Cement; Light-Cure Syringe; White; Refill
• 00841396105067: Nexus Third Generation; Light Cure Resin Cement; Light-Cure Syringe; Clear; Refill
• 00841396105050: Nexus Third Generation; Dual-Cure Resin Cement; Automix Dual-Cure Syringe; White Opaque; Refill
• 00841396105043: Nexus Third Generation; Dual-Cure Resin Cement; Automix Dual-Cure Syringe; Bleach; Refill
• 00841396103780: Nexus Third Generation; Dual-Cure Resin Cement; Automix Dual-Cure Syringe; White; Refill
• 00841396103681: Nexus Third Generation; Dual-Cure Resin Cement; Automix Dual-Cure Syringe; Yellow; Refill
• 00841396100079: Nexus Third Generation; Dual-Cure Resin Cement; Automix Dual-Cure Syringe; Clear; Refill