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510(k) Data Aggregation

    K Number
    K241283
    Device Name
    Elemental Granulate
    Manufacturer
    Zinkh NV
    Date Cleared
    2025-01-03

    (241 days)

    Product Code
    OLR, EMA
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    OLR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Elemental Granulate is a periodontal wound dressing intended to protect injured periodontal tissue as surgical sites.
    Device Description
    Elemental Granulate is a thermoplastic and non-resorbable medical device, which under in vitro conditions is found to be bacteriostatic. Material consistency is plastic-like and highly moldable after heating. Hardening starts 30 to 60 seconds after taking it away from the heat source. Hardens into a rigid material after approximately 90 seconds. Individual granules may slightly differ in size. For use only by a dental professional in the recommended indications.
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    K Number
    K230529
    Device Name
    HealiAid Dental Collagen Wound Dressing
    Manufacturer
    Maxigen Biotech Inc.
    Date Cleared
    2023-11-22

    (268 days)

    Product Code
    OLR
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    OLR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HealiAid® Dental Collagen Wound Dressing is indicated for the management of oral wounds and sores, including: 1. Denture sores 2. Oral ulcers (non-infected or viral) 3. Periodontal surgical wounds 4. Extraction sites 5. Surgical wounds. 6. Traumatic wounds
    Device Description
    The subject device is HealiAid® Dental Collagen Wound Dressing (HealiAid Dental) that is a white, porous, pliable and absorbable collagen wound dressing. HealiAid Dental is fabricated by fibrous collagen matrix purified from bovine Achilles tendons. HealiAid Dental is pliable and can be applied easily to oral wounds to protect the wound bed. The product is supplied in a sterile, nonpyrogenic package, and is indicated for single use only.
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    K Number
    K221428
    Device Name
    PerioStom Dental Dressing
    Manufacturer
    Forward Science LLC
    Date Cleared
    2022-12-22

    (220 days)

    Product Code
    OLR, MGQ
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    OLR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PerioStom™ Dental Dressing is an oral wound dressing intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. PerioStom™ Dental Dressing can be utilized for the pain relief and protection of oral mucosa due to irritation, trauma, or following iatrogenic procedures such as scaling and root planing.
    Device Description
    PerioStom™ Dental Dressing is a powder based wound dressing comprised entirely of spray-dried chitosan. PerioStom™ Dental Dressing is provided to the clinician in a stainless steel container and can be applied to the tissue via a dental instrument of their choice (e.g. a Prichard or Howard Periosteal Elevator) or a dry gloved finger. PerioStom™ Dental Dressing is also supplied in preloaded cartridges for application to harder to reach areas of the oral mucosa via the FS Dispenser™.
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    K Number
    K211851
    Device Name
    Ora-Aid
    Manufacturer
    TBM Corporation
    Date Cleared
    2022-01-11

    (210 days)

    Product Code
    OLR, MGQ
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    OLR

    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
    K210211
    Device Name
    PuraStat-OM
    Manufacturer
    3-D Matrix, Inc.
    Date Cleared
    2021-10-08

    (254 days)

    Product Code
    OLR, MGQ
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    OLR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PuraStat-OM adheres to oral tissue and forms a protective barrier over the wound to prevent further irritation and contamination. It provides a moist wound environment required for optimal wound healing. Manages pain of, for example: - All types of oral wounds, mouth sores, injuries and ulcers of the oral mucosa - Canker sores and cold sores - Irritation and traumatic ulcers such as those caused by various appliances such as braces, brackets, full and partial dentures and palatal expanders - Soft tissue pain from orthodontics - Aphthous ulcers - Extraction site pain - Oral mucositis and stomatitis (may be caused by chemotherapy or radiotherapy)
    Device Description
    PuraStat-OM is a sterile gel composed of a synthetic peptide and sterile water for injection. It is provided as a prefilled syringe (2.5% peptide content) ready for use as an oral hydrogel wound dressing with the sterile application nozzle. The gel's primary mode of action is that it adheres to the wound surface, conforms to the contours of the wound, and protects the wound from contamination and irritation by forming a protective barrier that is similar to the natural mucosa. It also creates and maintains a moist wound environment, which is necessary for the natural healing process. PuraStat-OM is completely non-animal and non-plant derived and contains no drugs or biologics that might present a risk of allergic reaction or skin irritation. Exposure to physiological fluids such as blood causes the peptide solution to quickly form a transparent gel without expansion in volume.
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    K Number
    K203091
    Device Name
    MucoLock Oral Gel
    Manufacturer
    PCCA, Inc.
    Date Cleared
    2021-02-12

    (122 days)

    Product Code
    OLR
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    OLR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MucoLock has a mechanical action which provides management of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies, including: Oral Mucositis or Stomatitis (may be caused by chemotherapy or radiotherapy), irritation due to oral surgery, traumatic ulcers caused by braces and ill-fitting dentures, or disease. Also indicated for diffuse aphthous ulcers.
    Device Description
    MucoLock® is a low viscosity, pourable, and swish-able gel, which is presented in 16 fl. oz. bottles. This product, when washed around the mouth, forms a protective layer over the oral mucosa.
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    K Number
    K202000
    Device Name
    Silatrix Oral Gel
    Manufacturer
    SA3, LLC
    Date Cleared
    2020-11-20

    (123 days)

    Product Code
    OLR, FRO, MGQ
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    OLR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Silatrix Oral Gel forms a protective layer over the oral mucosa by adhering to the mucosal surface which allows it to protect against further irritation and relieve pain. The oral gel may be used in the management of mouth lesions including aphthous ulcer, stomatitis, mucositis, minor lesions, chafing and traumatic ulcers, abrasions caused by braces and ill-fitting dentures, and lesions associated with oral surgery.
    Device Description
    The proposed Silatrix Oral Gel is an amorphous hydrogel formed by the controlled reaction of sucralfate with a limited quantity of malic acid and calcium carbonate solution. The amorphous hydrogel formed by this reaction binds reversibly to wounds and is intended to form a protective film that covers wounds, protects against further irritation and relieves pain. The intended use of this device is achieved by physical action. Silatrix Oral Gel may be administered directly to an accessible oral wound to provide an adherent physical covering of the wound bed. Although prepared by the reaction of sucralfate with an acid, the polymerized sucralfate self-buffers to a pH 5.0 - 7 .0, the subject device achieves its primary mode of action through serving as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. There is no chemical action or metabolic effect associated with the mechanism of action of this device. Silatrix Oral Gel contains sucralfate, malic acid, calcium carbonate, calcium sulfate dihydrate, sucralose, xanthan gum, propylene glycol, and purified water. Silatrix Oral Gel, which is labeled for prescription use only, is supplied non-sterile in a small tube.
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    K Number
    K193336
    Device Name
    Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse
    Manufacturer
    Synedgen, Inc.
    Date Cleared
    2020-05-27

    (177 days)

    Product Code
    OLR, MGO, MGQ
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    OLR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Synvaza manages the pain in many types of oral wounds, mouth sores, injuries, and ulcers of the oral mucosa. It adheres to oral tissue and forms a protective barrier between the wound and contamination. It provides the moist wound environment required for optimal wound healing. Manages pain associated with oral wounds, mouth sores, injuries and ulcers of the mouth such as: canker sores, irritation and traumatic ulcers.
    Device Description
    Synvaza is an oral wound rinse specifically formulated with moisturizers, humectants, and mucoadhesive biopolymers that are designed to manage the pain in many types of oral wounds, mouth sores, injuries, and ulcers of the oral mucosa. When swished around the mouth, the mucoadhesive formulation results in a temporary formation of a protective coating over the oral mucosa. The liquid also provides a moist wound environment, which is required for optimal wound healing. Synvaza is supplied in plastic bottles with and without a hand pump.
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    K Number
    K191987
    Device Name
    Orapeutic
    Manufacturer
    Forward Science
    Date Cleared
    2019-11-27

    (125 days)

    Product Code
    OLR, MGQ
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    OLR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Orapeutic™ Oral Pain Gel manages the pain of oral wounds, mouth sores, injuries and ulcers of the oral mucosa. It adheres to oral tissue and forms a protective barrier between the wound and further irritation & contamination. Orapeutic™ Oral Pain Gel also maintains a moist wound environment.
    Device Description
    Orapeutic™ Oral Pain Gel is a viscous hydrogel wound dressing composed entirely of food grade ingredients including a food grade preservative system. It is designed to be physiologically compatible with both intact and compromised tissue in the mouth to manage the pain associated with injuries to the mouth. Orapeutic Oral Pain Gel's primary mode of action for pain relief is that it adheres to the wound surface, conforms to the contours of the wound, and protects the wound from contamination and irritation by forming a protective barrier. It also maintains a moist wound environment. Orapeutic Oral Pain Gel is provided in 10mL syringes.
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    K Number
    K183436
    Device Name
    OraCure
    Manufacturer
    TBM Corporation
    Date Cleared
    2019-09-18

    (281 days)

    Product Code
    OLR, MGQ
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    OLR

    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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