Maxcem Elite 34417

GUDID 00841396108068

Self-Etch / Self-Adhesive Resin Cement; Intro Kit: 2 syringes Clear, 1 syringe White

Kerr Corporation

Dental composite resin

• Primary Device ID: 00841396108068
• NIH Device Record Key: 346d3a96-ee8e-4597-a6a2-b8b6eb53295b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Maxcem Elite
• Version Model Number: 34417
• Catalog Number: 34417
• 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: 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: +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: 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841396108068 [Primary]

FDA Product Code

• MZW: DENTAL CEMENT W/OUT ZINC-OXIDE EUGENOL AS AN ULCER COVERING FOR PAIN RELIEF

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-08-01

On-Brand Devices [Maxcem Elite]

• 00841396183546: 36664
• 00841396108068: Self-Etch / Self-Adhesive Resin Cement; Intro Kit: 2 syringes Clear, 1 syringe White
• 00841396107238: Self-Etch / Self-Adhesive Resin Cement; Sample (NA) - Not For Resale
• 10841396105255: Universal Resin Cement ; Bulk Pack
• 10841396105224: Universal Resin Cement; Refill Kit; Brown
• 10841396105217: Universal Resin Cement with Cleanup Indicator; Refill Kit; Yellow
• 10841396105200: Universal Resin Cement; Refill Kit; White Opaque
• 10841396105194: Universal Resin Cement; Refill Kit; White
• 10841396105187: Universal Resin Cement; Refill Kit; Clear