Cerinate® LUM1005
GUDID D813LUM10050
LUMINEERS STARTER KIT
DEN-MAT HOLDINGS, LLC
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 | D813LUM10050 |
| NIH Device Record Key | 9571300b-d492-4496-915c-89bb529cf4a0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cerinate® |
| Version Model Number | LUM1005 |
| Catalog Number | LUM1005 |
| Company DUNS | 809857704 |
| Company Name | DEN-MAT HOLDINGS, LLC |
| 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 | 1-800-433-6628 |
| info@denmat.com | |
| Phone | 1-800-433-6628 |
| info@denmat.com | |
| Phone | 1-800-433-6628 |
| info@denmat.com | |
| Phone | 1-800-433-6628 |
| info@denmat.com | |
| Phone | 1-800-433-6628 |
| info@denmat.com | |
| Phone | 1-800-433-6628 |
| info@denmat.com | |
| Phone | 1-800-433-6628 |
| info@denmat.com | |
| Phone | 1-800-433-6628 |
| info@denmat.com | |
| Phone | 1-800-433-6628 |
| info@denmat.com | |
| Phone | 1-800-433-6628 |
| info@denmat.com | |
| Phone | 1-800-433-6628 |
| info@denmat.com | |
| Phone | 1-800-433-6628 |
| info@denmat.com | |
| Phone | 1-800-433-6628 |
| info@denmat.com | |
| Phone | 1-800-433-6628 |
| info@denmat.com | |
| Phone | 1-800-433-6628 |
| info@denmat.com | |
| Phone | 1-800-433-6628 |
| info@denmat.com | |
| Phone | 1-800-433-6628 |
| info@denmat.com |
Operating and Storage Conditions
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 * Keep refrigerated for maximum shelf life |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to source of ignition or open flame |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 * Keep refrigerated for maximum shelf life |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to source of ignition or open flame |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 * Keep refrigerated for maximum shelf life |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to source of ignition or open flame |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 * Keep refrigerated for maximum shelf life |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to source of ignition or open flame |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 * Keep refrigerated for maximum shelf life |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to source of ignition or open flame |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 * Keep refrigerated for maximum shelf life |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to source of ignition or open flame |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 * Keep refrigerated for maximum shelf life |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to source of ignition or open flame |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 * Keep refrigerated for maximum shelf life |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to source of ignition or open flame |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 * Keep refrigerated for maximum shelf life |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to source of ignition or open flame |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 * Keep refrigerated for maximum shelf life |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to source of ignition or open flame |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 * Keep refrigerated for maximum shelf life |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to source of ignition or open flame |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 * Keep refrigerated for maximum shelf life |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to source of ignition or open flame |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 * Keep refrigerated for maximum shelf life |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to source of ignition or open flame |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 * Keep refrigerated for maximum shelf life |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to source of ignition or open flame |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 * Keep refrigerated for maximum shelf life |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to source of ignition or open flame |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 * Keep refrigerated for maximum shelf life |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to source of ignition or open flame |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D813LUM10050 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K881918
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 | 2016-09-24 |
On-Brand Devices [Cerinate®]
| D813LUM10050 | LUMINEERS STARTER KIT |
| D8130339099500 | CERI SH MOD II SYS CUSTOM KIT |
| D8130339099000 | SH MOD II SYSTEM BY CERINATE |
| D8130313811000 | LUMINEERS PLACEMENT KIT |
| D813030967101B0 | TETRAPQ D/C INIT 4g |
| D8130304025501 | ETCH'N'SEAL RED 8pc SY KIT |
Trademark Results [Cerinate]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CERINATE 73523399 1362864 Live/Registered |
DEN-MAT, INC. 1985-02-22 |
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