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HybenX® OTD Gel
EUDAMEDFDA UDIClass I (EU MDR)
Ref 103-5002Model HYBENX OTD – 2 pack – 103-5002
Identity
- Trade Name
- HybenX® OTD Gel EUDAMEDHYBENX Advanced Dental Debridement Gel FDA UDI
- Generic Name
- Dental mouthwash FDA UDI
- Device Name
- HYBENX OTD Gel EUDAMEDHYBENX 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. FDA UDI
- Model / Reference
- HYBENX OTD – 2 pack – 103-5002 EUDAMED103-5002 EUDAMED109-0004 FDA UDI
- Description
- HYBENX 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. FDA UDI
Identifiers
- Catalog Number
- 109-0004 FDA UDI
- Primary DI / UDI-DI
- 00860004740322 EUDAMEDFDA UDI
- Basic UDI-DI
- 03629421035002GA EUDAMED
- FDA Product Code
- KJJ FDA UDI
- EMDN Code
- Q019007 BUCCAL TOPICAL TREATMENT PREPARATIONS NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Dental mouthwash FDA UDI
Classification
- Device Class
- Class I EUDAMEDU FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 1.5 Milliliter FDA UDI
HybenX® OTD Gel by Epien Medical, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 03629421035002GA | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- EPIEN Medical, Inc
- EUDAMED SRN
- US-MF-000008278
- Authorised Representative
- QNET B.V. NL-AR-000002695
Sources (2)
- EUDAMED ba2b5b36-7c02-4180-b251-2a3afbc89083 61 fields · synced Jun 19, 2026
- FDA UDI 389fd3aa-48c9-45d5-b097-4e41325f154b 37 fields · synced May 29, 2026