| Primary Device ID | 00860004740308 |
| NIH Device Record Key | 03aeb177-f2bf-4e88-b7f1-c62186e23ef1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HYBENX Root Canal Cleanser |
| Version Model Number | 101-2002 |
| Company DUNS | 128678765 |
| Company Name | Epien Medical, Inc. |
| 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 | true |
| 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 |
| Total Volume | 2 Milliliter |
| Total Volume | 2 Milliliter |
| Total Volume | 2 Milliliter |
| Total Volume | 2 Milliliter |
| Total Volume | 2 Milliliter |
| Total Volume | 2 Milliliter |
| Total Volume | 2 Milliliter |
| Total Volume | 2 Milliliter |
| Total Volume | 2 Milliliter |
| Total Volume | 2 Milliliter |
| Total Volume | 2 Milliliter |
| Total Volume | 2 Milliliter |
| Total Volume | 2 Milliliter |
| Total Volume | 2 Milliliter |
| Total Volume | 2 Milliliter |
| Total Volume | 2 Milliliter |
| Total Volume | 2 Milliliter |
| Total Volume | 2 Milliliter |
| Total Volume | 2 Milliliter |
| Total Volume | 2 Milliliter |
| Total Volume | 2 Milliliter |
| Total Volume | 2 Milliliter |
| Total Volume | 2 Milliliter |
| Total Volume | 2 Milliliter |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860004740308 [Primary] |
| KJJ | Cleanser, Root Canal |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-05-28 |
| Device Publish Date | 2021-05-20 |
| 00860004740322 - HYBENX Advanced Dental Debridement Gel | 2023-05-17 HYBENX Advanced Dental Debridement is a topical liquid or gel intended for use as an adjunctive decontamination rinse of tooth s |
| 00860004740315 - HYBENX Advanced Dental Debridement | 2023-05-16 HYBENX Advanced Dental Debridement is topical liquid or gel intended for use as an adjunctive decontamination rinse of tooth sur |
| 00860004740308 - HYBENX Root Canal Cleanser | 2021-05-28EPIEN Root Canal Cleanser is indicated for use as an adjunctive rinse of tooth root canal systems and adjacent tooth surfaces during standard professional dental procedures to enhance the removal of post-instrumentation dentinal debris and smear-layer within the root canal system. |
| 00860004740308 - HYBENX Root Canal Cleanser | 2021-05-28 EPIEN Root Canal Cleanser is indicated for use as an adjunctive rinse of tooth root canal systems and adjacent tooth surfaces du |