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510(k) Data Aggregation
K Number
K222459Device Name
Centrix FluoroSilver Silver Diamine Fluoride 38%
Manufacturer
Centrix Inc
Date Cleared
2023-10-27
(438 days)
Product Code
PHR
Regulation Number
872.3260Why did this record match?
Applicant Name (Manufacturer) :
Centrix Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Treatment of Dental Hypersensitivity for use in adults over the age of 21.
Device Description
The Centrix FluoroSilver is a professional tooth desensitizer that is composed of Aqueous Silver Diamine Fluoride, 38.3% to 43.2% w/v. The solution is composed of water, ammonia, fluoride, silver and a colorant. The device is provided in a single 5 ml squeezable dropper bottle or a multi-pack which includes three 5 ml squeezable dropper bottles. Each variation is packaged in a preformed trav and includes applicators and the Instructions for Use (IFU). The primary mode of action is to reduce dentinal hypersensitivity by occluding open dentin tubules by the formation of a precipitate.
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K Number
K200764Device Name
STATSTIX
Manufacturer
Centrix Incorporated
Date Cleared
2020-10-15
(205 days)
Product Code
MVL
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Centrix Incorporated
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
StatStix is applied to control temporary bleeding caused by minor cuts and abrasions that may occur on gingival tissue during dental procedures.
Device Description
StatStix is designed incorporating a hand-held polypropylene handle with a nylon polyamide applicator tip coated with a dried solution of 25% Aluminum Sulfate Hydrate Solution with Mint Flavor. The device is configured in two sizes to help control minor gingival bleeding intended for transient use by a dentist during dental restorative procedures.
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