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510(k) Data Aggregation
K Number
K982009Device Name
ONE WEEK BACKSTOP DENTAL ANTI-RETRACTION CHECK VALVE
Manufacturer
Date Cleared
1998-06-25
(84 days)
Product Code
Regulation Number
872.6640Why did this record match?
Applicant Name (Manufacturer) :
SCITECH SOLUTIONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The BACSTOP™ dental waterline Anti-retraction valve is normally closed disposable valve, which is replaced every week, or 5 working days. It is intended to be used in-line on dental unit water lines as a means of preventing the retraction of orally contaminated fluids into the coolant and irrigant water hoses. It is to be used for all patients.
BACSTOP™ is to be installed within the last several inches of tubing, before the dental handpiece, air/water syringe or ultra sonic scaler. It opens only under sufficient pressure (equivalent to 1.5 psi) and snaps closed and seals against backflow when the pressure drops below this point. The device is inserted by connection to luer mounts placed permanently in-line.
Device Description
BacStop™ valve is a weekly disposable, normally closed antiretraction check valve, consisting of a flat silastic rubber disc valve membrane in a housing made up of top and bottom parts, united by a sonically sealed joint. The two parts of the valve housing are made of clear Lexan 124R Polycarbonate, with the top (entry) port being in the form of a female Luer fitting, and the bottom (exit) port being in the form of a male Luer fitting, with locking collar. Total length of the device is 0.93 inches, width 0.5 inches. The nominal cracking (opening) pressure for the check-valve is 1.5 psi.
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K Number
K973996Device Name
CLEARLINE PLUS, DENTAL WATERLINE FILTER
Manufacturer
Date Cleared
1998-02-04
(106 days)
Regulation Number
872.6640Why did this record match?
Applicant Name (Manufacturer) :
SCITECH SOLUTIONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
CLEARLINE PLUS™ is a disposable, combined 0.22 micron filter and anti-retraction check valve for use in dental unit water lines. It is intended to be used, in line, as a means of controlling bacteriological contaminants in the dental water and preventing the retraction of orally contaminated fluids into the dental line. It is to be used for all patients and changed every week, or 5 working days.
Device Description
Clearline Plus is a disposable microfiltration cartridge with approximately 10 sq. cms. of polyethersulfone membrane with 0.2 micron pores and a normally closed check valve at the exit port. The check valve has a silastic rubber membrane which operates with a cracking pressure of 1.5 psi.
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K Number
K960556Device Name
BACSTOP DENTAL ANTI-RETRACTION CHECK VALVE
Manufacturer
Date Cleared
1996-05-08
(89 days)
Product Code
Regulation Number
872.6640Why did this record match?
Applicant Name (Manufacturer) :
SCITECH SOLUTIONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
BACSTOP is intended for use in dental unit waterlines as a means of preventing the retraction of orally contaminated finids into the coolant and irrigant water hoses. The unit is intended to be used for one day only, and is then to be discarded, and replaced daily.
Device Description
BACSTOP is a disposable, normally closed Anti-retraction check valve, consisting of a flat silastic rubber disc valve membrane in a housing made up of top and bottom parts, united by a sonically sealed joint. The two parts of the valve housing are made of clear Lexan 124R Polycarbonate, with the top (entry) port being in the form of a female Luer fitting, and the bottom (exit) port being in the form of a male Luer fitting, with locking collar. Total length of the device is 0.93 inches, width 0.5 inches. Nominal Cracking (Opening) pressure for the valve is 1.5 PSI.
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