Cerinate® 031381100
GUDID D8130313811000
LUMINEERS PLACEMENT KIT
DEN-MAT HOLDINGS, LLC
Dental composite resin| Primary Device ID | D8130313811000 |
| NIH Device Record Key | 62205567-892b-4030-a0f0-2cbd4ec92207 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cerinate® |
| Version Model Number | 031381100 |
| Catalog Number | 031381100 |
| 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 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Handling Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Handling Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Handling Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Handling Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Handling Environment Temperature | Between 33 Degrees Fahrenheit and 75 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 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Handling Environment Temperature | Between 33 Degrees Fahrenheit and 75 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 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Handling Environment Temperature | Between 33 Degrees Fahrenheit and 75 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 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Handling Environment Temperature | Between 33 Degrees Fahrenheit and 75 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 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Handling Environment Temperature | Between 33 Degrees Fahrenheit and 75 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 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Handling Environment Temperature | Between 33 Degrees Fahrenheit and 75 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 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Handling Environment Temperature | Between 33 Degrees Fahrenheit and 75 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 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Handling Environment Temperature | Between 33 Degrees Fahrenheit and 75 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 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Handling Environment Temperature | Between 33 Degrees Fahrenheit and 75 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 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Handling Environment Temperature | Between 33 Degrees Fahrenheit and 75 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 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Handling Environment Temperature | Between 33 Degrees Fahrenheit and 75 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 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Handling Environment Temperature | Between 33 Degrees Fahrenheit and 75 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 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Handling Environment Temperature | Between 33 Degrees Fahrenheit and 75 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 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Handling Environment Temperature | Between 33 Degrees Fahrenheit and 75 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 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Handling Environment Temperature | Between 33 Degrees Fahrenheit and 75 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 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Handling Environment Temperature | Between 33 Degrees Fahrenheit and 75 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 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Handling Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D8130313811000 [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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