Identity
- Trade Name
- BenaCel FDA UDI
- Generic Name
- General oral wound dressing, non-animal-derived, sterile FDA UDI
- Device Name
- BenaCel® dental dressing is made of biocompatible oxidized cellulose and contains no chemical additives. BenaCel® dental dressing adheres to moist oral mucosa and forms a temporary barrier protecting the wound from further irritation and pain. When placed in the extraction socket, BenaCel® dental dressing forms a gelatinous scaffold in the blood extrude, facilitating the development of a stable blood clot to prevent dry socket formation. BenaCel® dental dressing is designed for use in the extraction site and the management of bleeding and alveolar osteitis (dry socket). It may also be used as a wound dressing for the temporary management of oral surgical wounds, such as operative, postoperative, donor sites and traumatic injuries. FDA UDI
- Model / Reference
- C-004 FDA UDI
- Description
- BenaCel® dental dressing is made of biocompatible oxidized cellulose and contains no chemical additives. BenaCel® dental dressing adheres to moist oral mucosa and forms a temporary barrier protecting the wound from further irritation and pain. When placed in the extraction socket, BenaCel® dental dressing forms a gelatinous scaffold in the blood extrude, facilitating the development of a stable blood clot to prevent dry socket formation. BenaCel® dental dressing is designed for use in the extraction site and the management of bleeding and alveolar osteitis (dry socket). It may also be used as a wound dressing for the temporary management of oral surgical wounds, such as operative, postoperative, donor sites and traumatic injuries. FDA UDI
Identifiers
- Catalog Number
- B01-0408 FDA UDI
- Primary DI / UDI-DI
- D767B0104081 FDA UDI
- 510(k) Number
- K090612 FDA UDI
- FDA Product Code
- MGQ FDA UDI
- GMDN Term
- General oral wound dressing, non-animal-derived, sterile FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: General oral wound dressing, non-animal-derived, sterile
BenaCel by Unicare Biomedical, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General oral wound dressing, non-animal-derived, sterile.
- FASTRACT — BENCO DENTAL SUPPLY CO. · U
- HEMOCELL — Huizhou Foryou Medical Devices Co., Ltd. · U
- 3D Dental- Bioviva — 3D DENTAL DESIGNS AND DEVELOPMENT, LLC · U
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · U
- BenaCel — UNICARE BIOMEDICAL, INC. · U
- BenaCel — UNICARE BIOMEDICAL, INC. · U
- BenaCel — UNICARE BIOMEDICAL, INC. · U
- BenaCel — UNICARE BIOMEDICAL, INC. · U
Cleared under the same submission
K090612 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Unicare Biomedical, Inc.
Sources (1)
- FDA UDI 51a43cdf-d142-4058-8458-4fc7e8a0018e 37 fields · synced May 30, 2026