Infinity® 039620150
GUDID D8130396201500
INFINITY ORIGINAL A & B KIT
DEN-MAT HOLDINGS, LLC
Dental composite resin| Primary Device ID | D8130396201500 |
| NIH Device Record Key | a0dbea18-9e48-4231-bda8-67adb75687d4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Infinity® |
| Version Model Number | 039620150 |
| Catalog Number | 039620150 |
| 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 | |
| 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 | |
| Phone | 1-800-433-6628 |
| info@denmat.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate Infinity for maximum shelf-life |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate Infinity for maximum shelf-life |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate Infinity for maximum shelf-life |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate Infinity for maximum shelf-life |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate Infinity for maximum shelf-life |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate Infinity for maximum shelf-life |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate Infinity for maximum shelf-life |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate Infinity for maximum shelf-life |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate Infinity for maximum shelf-life |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate Infinity for maximum shelf-life |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate Infinity for maximum shelf-life |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate Infinity for maximum shelf-life |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate Infinity for maximum shelf-life |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate Infinity for maximum shelf-life |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate Infinity for maximum shelf-life |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate Infinity for maximum shelf-life |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate Infinity for maximum shelf-life |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate Infinity for maximum shelf-life |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate Infinity for maximum shelf-life |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate Infinity for maximum shelf-life |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate Infinity for maximum shelf-life |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate Infinity for maximum shelf-life |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate Infinity for maximum shelf-life |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate Infinity for maximum shelf-life |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate Infinity for maximum shelf-life |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate Infinity for maximum shelf-life |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate Infinity for maximum shelf-life |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate Infinity for maximum shelf-life |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate Infinity for maximum shelf-life |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate Infinity for maximum shelf-life |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate Infinity for maximum shelf-life |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate Infinity for maximum shelf-life |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate Infinity for maximum shelf-life |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate Infinity for maximum shelf-life |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D8130396201500 [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 [Infinity®]
| D81380000 | SOLVENEX 8oz |
| D8130396901100 | INFINITY SY INTRO KIT |
| D8130396812000 | INFINITY SE SY VALUE KIT |
| D8130396802000 | INFINITY SE SY KIT |
| D8130396801000 | INFINITY SY VALUE KIT |
| D8130396701000 | INFINITY SY KIT |
| D8130396201500 | INFINITY ORIGINAL A & B KIT |
| D8130396810300 | INFNTY DCHMB SY SMP BG 1FLW IT |
Trademark Results [Infinity]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INFINITY 98761246 not registered Live/Pending |
Zevex, Inc. 2024-09-20 |
 INFINITY 98737979 not registered Live/Pending |
Marten Group, Inc. 2024-09-06 |
 INFINITY 98643936 not registered Live/Pending |
Project Management Institute, Inc. 2024-07-11 |
 INFINITY 98470220 not registered Live/Pending |
IBF IP, LLC 2024-03-27 |
 INFINITY 98466286 not registered Live/Pending |
IBF IP, LLC 2024-03-25 |
 INFINITY 98454204 not registered Live/Pending |
Tanks By Mail Inc 2024-03-18 |
 INFINITY 98433629 not registered Live/Pending |
Infinity Generation Inc. 2024-03-05 |
 INFINITY 98338571 not registered Live/Pending |
Careismatic Brands, LLC 2024-01-02 |
 INFINITY 98293120 not registered Live/Pending |
PREFERRED COLLECTIONS INC. 2023-11-30 |
 INFINITY 98275942 not registered Live/Pending |
Capital One Financial Corporation 2023-11-17 |
 INFINITY 98242984 not registered Live/Pending |
IGH Holding Inc. 2023-10-27 |
 INFINITY 98175956 not registered Live/Pending |
CellFE, Inc. 2023-09-12 |
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