Geristore® 030451110
GUDID D8130304511100
BIO-CAP KIT
DEN-MAT HOLDINGS, LLC
Dental composite resin| Primary Device ID | D8130304511100 |
| NIH Device Record Key | 54cbfb45-5cec-4aa6-8f4c-793c41a57e2f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Geristore® |
| Version Model Number | 030451110 |
| Catalog Number | 030451110 |
| 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 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| 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 |
| Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D8130304511100 [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 [Geristore®]
| D81345060 | GERISTORE A S/S 10g |
| D813034526101B0 | GERISTORE PST B SH A3.5 10g |
| D8130345241010 | GERISTORE PST B SH A3 10g |
| D8130345231010 | GERISTORE PST B SH A2 10g |
| D8130345221010 | GERISTORE PST B SH A1 10g |
| D8130314793000 | HOLISTORE A AND B JARS |
| D8130314771000 | GERISTORE VALUE CUSTOM KIT |
| D8130314761100 | GERISTORE A2 SY INTRO KIT |
| D8130314585500 | GERISTORE VALUE SY KIT A2 |
| D8130314577300 | GERISTORE SY KIT A3.5 |
| D8130314577200 | GERISTORE SY KIT A3 |
| D8130314575200 | GERISTORE VALUE SY KIT A3 |
| D8130314575000 | GERISTORE SY KIT A2 |
| D8130304511100 | BIO-CAP KIT |
| D813030450911B0 | GERISTORE A S/S 10g |
| D8130398457300 | GERISTOR SY SMP A2 BAG 1FLW IT |
Trademark Results [Geristore]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GERISTORE 74194248 1706205 Live/Registered |
DEN-MAT HOLDINGS, LLC 1991-08-13 |
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