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510(k) Data Aggregation

    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?
    Applicant Name (Manufacturer) :

    Forward Science LLC

    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
    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?
    Applicant Name (Manufacturer) :

    Forward Science

    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
    K152406
    Device Name
    SalivaMAX
    Manufacturer
    FORWARD SCIENCE LLC
    Date Cleared
    2015-12-23

    (120 days)

    Product Code
    LFD
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    FORWARD SCIENCE LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SalivaMAX™ is indicated for dryness of the mouth or throat (hyposalivation, xerostomia, mucositis), regardless of the cause and regardless of whether the condition is temporary or permanent. Relief of dryness of the oral mucosa in these conditions is associated with an amelioration of pain. SalivaMAX™ is also indicated as an adjunct to standard oral care in treating the mucositis that may be caused by radiation or high dose chemotherapy. SalivaMAX™ may be used for the relief of dryness of the oral mucosa when hyposalivation results from the following: pre/post surgery, radiotherapy, chemotherapy, infection or dysfunction of the salivary glands, inflammation of the mouth or throat, fever, emotional factors such as fear or anxiety, obstruction of the salivary ducts, Bell's Palsy, and Sjogren's syndrome. SalivaMAX™ is also indicated for dryness of the oral mucosa due to drugs such as antihistamines, atropine, or other anticholinergeic agents that suppress salivary secretion. SalivaMAX™ may be used as part of an oral hygiene program for patients with dry mouth. SalivaMAX™ provides intensive hygiene of the oral cavity, and may be used to help relieve bad taste, relieve offensive nasal discharge, and crusting.
    Device Description
    SalivaMAX™ is an artificial saliva that is provided in disposable packets. SalivaMAX™ is comprised of powdered ingredients that when combined with 30 mL (1 oz.) of water, produces a supersaturated calcium phosphate solution. SalivaMAX™ is packaged in singleuse packets and will be provided non-sterile and is not intended to be sterilized before use. Because SalivaMAX™ is to be administered several times per day it will primarily be used at home, office or other non-clinical settings. However, SalivaMAXTM may also be used in clinical or healthcare facility settings where patients are receiving inpatient services. The goal of administering SalivaMAX™ is to relieve chronic and temporary xerostomia and mucositis. SalivaMAX™ is a partial substitute for natural saliva and intended to moisten, lubricate, and clean the oral cavity including the mucosa of the mouth, tongue, and throat. SalivaMAX™ facilitates chewing and speaking; and can relieve bad breath. SalivaMAX™ is composed of US Pharmacopeia grade calcium, phosphate, bicarbonate, and chloride electrolytes. Each application of SalivaMAX™ is to swish half the solution for 1 minute, expectorate, then repeat for the remaining solution. Given that the rinse is topical with a maximum rinse time of 20 minutes per day (2 minutes per application x maximum 10 times per day), SalivaMAX™ is considered a surface contacting device with a limited duration of contact. Key performance specifications of SalivaMAX™ are an in solution pH range of 6.25 - 7.5 and solubility in water.
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    K Number
    K123169
    Device Name
    ORALID
    Manufacturer
    FORWARD SCIENCE LLC
    Date Cleared
    2013-03-13

    (155 days)

    Product Code
    NXV
    Regulation Number
    872.6350
    Why did this record match?
    Applicant Name (Manufacturer) :

    FORWARD SCIENCE LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OralID™ is intended to be used by a dentist or physician as an adjunct to an oral examination to aid in visualization of oral mucosal abnormalities, such as oral cancer and pre-cancer.
    Device Description
    OrallD™ is a battery operated (CR123A), hand-held, oral illumination and examination light designed for use by dental and medical professionals to be used as an adjunctive tool for fluorescence visualization of oral mucosal tissue. OralID™ accessories include two pair of filtered eyewear for both the clinician and patient.
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