FDA UDI
Not in Commercial Distribution
🇺🇸 United States
HYBENX Root Canal Cleanser
DI: 00860004740308
·
Model: 101-2002
·
Epien Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HYBENX Root Canal Cleanser
- Primary DI
- 00860004740308
- Version / Model
- 101-2002
- Company Name
- Epien Medical, Inc.
- Labeler DUNS
- 128678765
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-20
- Public Version
- 2
- Public Version Date
- 2022-07-20
- Public Version Status
- Update
- Public Device Record Key
- 03aeb177-f2bf-4e88-b7f1-c62186e23ef1
- Distribution End Date
- 2021-12-31
Device Description
EPIEN 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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KJJ | Cleanser, Root Canal | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42345 | Dental mouthwash | A substance intended to be used to clean and disinfect the oral cavity (including teeth and gums) for personal hygiene and/or dental clinical procedures. It is available in various forms (e.g., liquid solution, dissolving tablets) which inhibit bacterial growth and sometimes provide specific benefits for teeth (e.g., fluoride, whitening agents). It is intended for use in the home or a clinical setting. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860004740308 | GS1 |
Customer Contacts
- Phone
- 6516533380
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K123538 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 2 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 59 – 86 Degrees Fahrenheit