| Primary Device ID | 00860004740322 |
| NIH Device Record Key | 389fd3aa-48c9-45d5-b097-4e41325f154b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HYBENX Advanced Dental Debridement Gel |
| Version Model Number | 109-0004 |
| Catalog Number | 109-0004 |
| 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 |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| 00860004740322 - HYBENX Advanced Dental Debridement Gel | 2023-05-17HYBENX Advanced Dental Debridement is a topical liquid or gel intended for use as an adjunctive decontamination rinse of tooth surfaces during the performance of certain dental procedures to help remove the smear layer and tooth debris. |
| 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 | 2021-05-28 EPIEN Root Canal Cleanser is indicated for use as an adjunctive rinse of tooth root canal systems and adjacent tooth surfaces du |