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510(k) Data Aggregation
K Number
K221428Device Name
PerioStom Dental Dressing
Manufacturer
Forward Science LLC
Date Cleared
2022-12-22
(220 days)
Product Code
OLR, MGQ
Regulation Number
N/AWhy 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
K152406Device Name
SalivaMAX
Manufacturer
FORWARD SCIENCE LLC
Date Cleared
2015-12-23
(120 days)
Product Code
LFD
Regulation Number
N/AWhy 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
K123169Device Name
ORALID
Manufacturer
FORWARD SCIENCE LLC
Date Cleared
2013-03-13
(155 days)
Product Code
NXV
Regulation Number
872.6350Why 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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