BenaCel

Primary DI
D767B0105081
Brand
BenaCel
Company
UNICARE BIOMEDICAL INC.
Model
C-004
Catalog number
B01-0408
Device 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.
Published
2021-07-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or BiologicUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090612000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090612000BENACELUnicare Biomedical2009-07-24OLR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D767B0104081PrimaryHIBCC0
D767B0105081Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General oral wound dressing, non-animal-derived, sterileA sterile device intended to be used as a protective cover for the general oral mucosa to treat surgical or traumatic wounds/lesions in the mouth. It consists primarily of one or more plant-derived and/or (bio)synthetic compound(s) and is supplied in various forms (e.g., plug, sheet, gel, fluid, spray) for use in the home or a clinical setting. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry, well ventilated environment. Keep out of sunlight.
Storage Environment Humidity0 Percent (%) Relative Humidity65 Percent (%) Relative Humidity
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
949-305-9600sales@unicarebiomedical.com

Regulatory Flags#

DUNS number
038023573
Device count
8
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D767C0701010CollaFlex15mm x 20mmC07-01012024-01-10
D767C0702010CollaFlex20mm x 30mmC07-02012024-01-10
D767C0703010CollaFlex30mm x 40mmC07-03012024-01-10
D767B0205101Benacel Plus5x5cmB02-05102024-07-12
D767B0210101Benacel Plus5x10cmB02-10102024-07-12
D767B0214101Benacel Plus5x20cmB02-14102024-07-12
D767B0222101Benacel Plus10x10cmB02-22102024-07-12
D767B0224101Benacel Plus10x15mmB02-24102024-07-12
D767B0226101Benacel Plus10x20mmB02-26102024-07-12
D767C0609010Perforated Cytoflex Ti-enforced19x26mmC06-09012024-07-12
D767C0613010Perforated Cytoflex Ti-enforced20x25mmC06-13012024-07-12
D767C0617010Perforated Cytoflex Ti-enforced25x30mmC06-17012024-07-12
D767C0635010Perforated Cytoflex Ti-enforced25x36mmC06-35012024-07-12
D767C0639010Perforated Cytoflex Ti-enforced30x41mmC06-39012024-07-12
D767C0641010Perforated Cytoflex Ti-enforced32x40mmC06-41012024-07-12
D767C0801010Perforated Tefguard12x24mmC08-01012024-07-12
D767C0802010Perforated Tefguard25x30mmC08-02012024-07-12
D767C0501010Cytoflex Ti-enforced13x20mmC05-01012024-01-10
D767C0503010Cytoflex Ti-enforced12x24mmC05-03012024-01-10
D767C0505010Cytoflex Ti-enforced14x24mmC05-05012024-01-10

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00383160000104Dash TopicAIM MEDICAL INC.MGQ2025-05-12
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