Geristore® 031476110
GUDID D8130314761100
GERISTORE A2 SY INTRO 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 | D8130314761100 |
| NIH Device Record Key | 7e17f681-7dbe-4074-98a8-e1713a78e2e3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Geristore® |
| Version Model Number | 031476110 |
| Catalog Number | 031476110 |
| 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 *Return to room temperature prior to use |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate for maximum shelf-life |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| 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 *Return to room temperature prior to use |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate for maximum shelf-life |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| 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 *Return to room temperature prior to use |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate for maximum shelf-life |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| 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 *Return to room temperature prior to use |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate for maximum shelf-life |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| 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 *Return to room temperature prior to use |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate for maximum shelf-life |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| 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 *Return to room temperature prior to use |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate for maximum shelf-life |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| 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 *Return to room temperature prior to use |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate for maximum shelf-life |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| 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 *Return to room temperature prior to use |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate for maximum shelf-life |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| 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 *Return to room temperature prior to use |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate for maximum shelf-life |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| 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 *Return to room temperature prior to use |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate for maximum shelf-life |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| 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 *Return to room temperature prior to use |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate for maximum shelf-life |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| 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 *Return to room temperature prior to use |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate for maximum shelf-life |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| 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 *Return to room temperature prior to use |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate for maximum shelf-life |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| 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 *Return to room temperature prior to use |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate for maximum shelf-life |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| 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 *Return to room temperature prior to use |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate for maximum shelf-life |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| 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 *Return to room temperature prior to use |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate for maximum shelf-life |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| 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 | D8130314761100 [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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