KromaFaze
GUDID 10841396116688
Dust Free Color Changing Alginate Dental Impression Material Regular Set Value Pak
Kerr Corporation
Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material| Primary Device ID | 10841396116688 |
| NIH Device Record Key | a432066a-5682-4eb3-8d84-7769fc839279 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KromaFaze |
| Version Model Number | 27497DX |
| Company DUNS | 199354556 |
| Company Name | Kerr Corporation |
| Device Count | 8 |
| 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 | |
| Phone | +18005377123 |
| customercare@kavokerrgroup.com | |
| Phone | +18005377123 |
| customercare@kavokerrgroup.com | |
| Phone | +18005377123 |
| customercare@kavokerrgroup.com | |
| Phone | +18005377123 |
| customercare@kavokerrgroup.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a tightly closed container. Keep Dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a tightly closed container. Keep Dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a tightly closed container. Keep Dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a tightly closed container. Keep Dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a tightly closed container. Keep Dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a tightly closed container. Keep Dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a tightly closed container. Keep Dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a tightly closed container. Keep Dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a tightly closed container. Keep Dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a tightly closed container. Keep Dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a tightly closed container. Keep Dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a tightly closed container. Keep Dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a tightly closed container. Keep Dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a tightly closed container. Keep Dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a tightly closed container. Keep Dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a tightly closed container. Keep Dry. Keep away from sunlight. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841396116681 [Unit of Use] |
| GS1 | 10841396116688 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K160441
FDA Product Code
| ELW | MATERIAL, IMPRESSION |
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 | 2021-10-11 |
| Device Publish Date | 2017-08-31 |
On-Brand Devices [KromaFaze]
| 10841396116695 | Dust Free Color Changing Alginate Dental Impression Material Regular Set |
| 10841396116688 | Dust Free Color Changing Alginate Dental Impression Material Regular Set Value Pak |
| 10841396116671 | Dust Free Color Changing Alginate Dental Impression Material Fast Set |
| 10841396100946 | Dust Free Color Changing Alginate Dental Impression Material Fast Set Value Pack |
Trademark Results [KromaFaze]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 KROMAFAZE 74707861 2049863 Dead/Cancelled |
CADCO DENTAL PRODUCTS, INC. 1995-07-28 |
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