Maxcem Elite 34418
GUDID 10841396105255
Universal Resin Cement ; Bulk Pack
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| Primary Device ID | 10841396105255 |
| NIH Device Record Key | 4688ceba-e088-496e-927d-859c4f50c8c1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Maxcem Elite |
| Version Model Number | 34418 |
| Catalog Number | 34418 |
| Company DUNS | 199354556 |
| Company Name | Kerr Corporation |
| Device Count | 4 |
| 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 |
| customercare@kavokerrgroup.com | |
| Phone | +18005377123 |
| customercare@kavokerrgroup.com | |
| Phone | +18005377123 |
| customercare@kavokerrgroup.com | |
| Phone | +18005377123 |
| customercare@kavokerrgroup.com | |
| Phone | +18005377123 |
| customercare@kavokerrgroup.com | |
| Phone | +18005377123 |
| customercare@kavokerrgroup.com | |
| Phone | +18005377123 |
| customercare@kavokerrgroup.com | |
| Phone | +18005377123 |
| customercare@kavokerrgroup.com | |
| Phone | +18005377123 |
| customercare@kavokerrgroup.com | |
| Phone | +18005377123 |
| customercare@kavokerrgroup.com | |
| Phone | +18005377123 |
| customercare@kavokerrgroup.com | |
| Phone | +18005377123 |
| customercare@kavokerrgroup.com |
Device Dimensions
| Weight | 20 Gram |
| Weight | 20 Gram |
| Weight | 20 Gram |
| Weight | 20 Gram |
| Weight | 20 Gram |
| Weight | 20 Gram |
| Weight | 20 Gram |
| Weight | 20 Gram |
| Weight | 20 Gram |
| Weight | 20 Gram |
| Weight | 20 Gram |
| Weight | 20 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841396105258 [Unit of Use] |
| GS1 | 10841396105255 [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 | 3 |
| Public Version Date | 2021-03-18 |
| 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 |
Trademark Results [Maxcem Elite]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MAXCEM ELITE 86902615 5346910 Live/Registered |
Kerr Corporation 2016-02-09 |
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