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510(k) Data Aggregation
K Number
K211851Device Name
Ora-Aid
Manufacturer
TBM Corporation
Date Cleared
2022-01-11
(210 days)
Product Code
OLR, MGQ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
TBM Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intra-oral Wound Dressing is intended for the management of all types of oral wounds, injuries and ulcerations of the gingival and oral mucosa, including stomatitis, minor chafing and traumatic ulcers, abrasions caused by braces and illfitting dentures, and lesions associated with oral surgery.
Intra-oral Wound Dressing operates to relieve pain by adhering to and protecting affected tissues from further irritation, thereby allowing healing.
Device Description
Intra-oral Wound Dressing is a device comprised of an oral mucosa adhesive side and a protection side. The oral mucosa adhesive side is composed of a water soluble polymer that when exposed to moisture in the oral cavity changes into a gel state to achieve adhesion to the wound area. The protection side consists of a waterinsoluble polymer which covers the wound to protect the applicable area from the environment in the oral cavity. Intra-oral Wound Dressing is simply a non-sterile bandage to protect oral wounds.
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K Number
K183436Device Name
OraCure
Manufacturer
TBM Corporation
Date Cleared
2019-09-18
(281 days)
Product Code
OLR, MGQ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
TBM Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OraCure® is intended for use as an oral wound dressing to protect ulcer tissue by forming a physical barrier on the wound tissue to avoid further irritation and thus to relieve pain. It is indicated for use with all types of ulcers and small wounds of the oral mucosa including canker sores, aphthous ulcers, and injuries such as traumatic ulcers caused by self-biting, braces, and ill-fitting dentures.
Device Description
OraCure® is an oral wound dressing comprising a mucous-adhesive side on a protection side, wherein the adhesive side has a strong adhesion when it is applied and hydrated on mucus. Adhesive side is water-soluble polymer that reacts with moisture (water and saliva) in the mouth within a short time and changes into a gel state. The protection side for protection of the mucous-adhesive side consists of water-insoluble polymer on the protection side is insoluble in the water and covers the wound to protect the applicable area from the environment (bacteria, saliva, food, etc.) in the mouth. OraCure® does not contain any biological additives or drugs with respect to wound treatment, but it is simple non-sterile bandage to protect ulcer tissue.
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