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Found 18 results
510(k) Data Aggregation
K Number
K214057Device Name
STATIM 6000B Vacuum Autoclave
Manufacturer
SciCan Ltd.
Date Cleared
2022-03-31
(94 days)
Product Code
FLE
Regulation Number
880.6880Why did this record match?
Applicant Name (Manufacturer) :
SciCan Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The STATIM 600B are dynamic air removal (pre-vacuum) table-top steam sterilizers that are intended for use by a healthcare provider to sterilize medical products by means of pressurized steam.
The STATIM 6000B are suitable for the sterilization of dental and medical instruments that are validated to be sterilized by steam. The STATIM 6000B has not been designed to sterilize liquid loads, biomedical waste or materials not compatible with steam sterilization. The processing of such in incomplete sterlization and/or damage to the autoclave.
Device Description
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K Number
K210326Device Name
Bravo G4 Chamber Autoclave
Manufacturer
SciCan Ltd.
Date Cleared
2021-07-01
(147 days)
Product Code
FLE
Regulation Number
880.6880Why did this record match?
Applicant Name (Manufacturer) :
SciCan Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BRAVO G4 is a dynamic-air-removal (pre-vacuum) table-top steam sterlizer intended for use by a health care provider to sterilize medical products by means of pressurized steam.
It is suitable for the sterilization of dental and medical instruments that are validated to be steam. The BRAVO G4 has not been designed to sterilize liquid loads, biomedical waste or materials not compatible with steam sterilization. The processing of such loads may result in incomplete sterilization and / or damage to the autoclave.
Device Description
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K Number
K192910Device Name
STATClave G4 Chamber Autoclave
Manufacturer
SciCan Ltd.
Date Cleared
2020-06-19
(248 days)
Product Code
FLE
Regulation Number
880.6880Why did this record match?
Applicant Name (Manufacturer) :
SciCan Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The STATCLAVE G4 is a dynamic-air-removal (pre-vacuum) table-top steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam.
It is suitable for the sterilization of dental and medical instruments that are validated to be steam. The STATCLAVE G4 has not been designed to sterilize liquid loads, bio-medical waste or materials not compatible with steam sterilization. The processing of such loads may result in incomplete sterilization and / or damage to the autoclave.
Device Description
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K Number
K190062Device Name
STATCLAVE G4 Chamber Autoclave
Manufacturer
SciCan Ltd.
Date Cleared
2019-07-26
(192 days)
Product Code
FLE
Regulation Number
880.6880Why did this record match?
Applicant Name (Manufacturer) :
SciCan Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The STATCLAVE G4 is a dynamic-air-removal (pre-vacuum) table-top steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam.
It is suitable for the sterilization of dental and medical instruments that are validated to be steam. The STATCLAVE G4 has not been designed to sterilize liquid loads, bio-medical waste or materials not compatible with steam sterilization. The processing of such loads may result in incomplete sterilization and / or damage to the autoclave.
Device Description
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K Number
K172292Device Name
SALUS - Hygiene Instrument Reprocessing Container
Manufacturer
SciCan Ltd.
Date Cleared
2017-11-24
(116 days)
Product Code
KCT
Regulation Number
880.6850Why did this record match?
Applicant Name (Manufacturer) :
SciCan Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SALUS® - Hygiene is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. The SALUS® - Hygiene is a reusable instrument reprocessing container intended to enclose and organize instruments that are designed to withstand steam sterilization and to maintain sterility of the reusable instruments during storage. The SALUS - Hygiene is suitable for use in dynamic air removal steam sterilizers.
Device Description
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K Number
K132356Device Name
SANAO 200L, SANAO 40 /SANAO 40L, SANAO 10L, SANAO PSI / SANAO PSO, SANAO 40ST
Manufacturer
SCICAN GMBH
Date Cleared
2014-01-31
(186 days)
Product Code
EGS, CLA, SAN
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
SCICAN GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This medical device is only intended for dental treatment in the area of dentistry. Is is intended to be used for the following applications:
- SANAO 200 L / 40 ST: The removal of decayed matter, cavity and crown preparations, the removal of filings and surface finishing of tooth and restoration surfaces.
- SANAO 40 / 40 L. / 10 / 10 L.: Cavity preparations, caries excavation, endodontics, surface finishing of tooth and restoration surfaces.
- SANAO PSI / PSO: prophylaxis treatment.
Device Description
All SANAO Contra-Angle and Straight dental handpieces can be powered by an air-motor or an electronic micro-motor and are intended for use by trained professionals in the field of general dentistry. They are ergonomically shaped, reusable and some models are optionally available with a glass rod lighting system. Depending on the model the devices possess a 1- or 3- port spray or no spray. For different applications and tools there is a range of devices available with different transmissions for maximum output rotations ranging from 8,000 to 200,000 rpm. The devices are color-coded according to their respective gear ratio. The shanks of the instruments are in conformance with the respective ISO standards.
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K Number
K112872Device Name
STATIM 2000 G4 CASSETTE
Manufacturer
SCICAN LTD.
Date Cleared
2012-07-10
(284 days)
Product Code
FLE
Regulation Number
880.6880Why did this record match?
Applicant Name (Manufacturer) :
SCICAN LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The STATIM 2000/5000 G4 Cassette Autoclaves are steam flush pressure pulse dynamic air removal steam autoclaves designed for the reprocessing of reusable medical instruments to achieve successful sterilization in a clinical setting. They utilize saturated steam at high pressures in order to attain an effective kill of infectious bio-organisms.
The units are intended to sterilize heat and moisture stable medical instruments (including handpieces) which are commonly found in medical and dental offices, hospitals, clinics, and other facilities. The STATIM 2000/5000 G4 Cassette Autoclaves are only intended for heat stable instruments.
Device Description
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K Number
K090937Device Name
E-STATIS 40 SYSTEM
Manufacturer
SCICAN LTD.
Date Cleared
2009-07-24
(112 days)
Product Code
EBW
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
SCICAN LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The E-STATIS type 40 dental system is intended for use by dental professionals in the performance of dental restoration, prophylaxis and endodontic procedures.
The E-STATIS 40 System is intended for use in dentistry for restoration, prophylaxis and endodontic procedures. The system provides control for motorized handpieces by converting pneumatic output from the dental treatment center to permit the operation of electrically driven dental handpieces.
Device Description
The E-STATIS type 40 Electric Motor System is designed for use in various dental procedures including dental restoration, prophylaxis and endodontics. The system is comprised of a power supply, control unit, hose and a brushless micro motor.
The control unit is equipped with five customizable endo settings including torque control, with the option of auto-stop, auto-forward and auto-reverse-forward. In addition, there are also three standard customizable operative modes. All E-STATIS components are modular and can be placed wherever the operator chooses.
The inputs to the control unit are supplied by a control panel with touch screen operation. The touch-sensitive screen has clear, user friendly symbols and provides individual selection and usage of the parameters to the individual needs of the dentist. The touch pad is removable and can be mounted either internally or externally on the dental unit.
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K Number
K090265Device Name
BRAVO AUTOCLAVE, MODELS 17, 17V AND 21V
Manufacturer
SCICAN LTD.
Date Cleared
2009-05-15
(101 days)
Product Code
FLE
Regulation Number
880.6880Why did this record match?
Applicant Name (Manufacturer) :
SCICAN LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BRAVO series of Autoclaves are intended to be used in medical and dental practices, hospitals, clinics and other associated facilities to sterilize re-usable medical and dental instruments (including dental handpieces) and medical materials that are heat and moisture resistant and compatible with the steam sterilization process.
The BRAVO series of Autoclaves are not intended nor recommended for the sterilization of fluids, liquids, or pharmaceutical products.
Device Description
The BRAVO series of Autoclaves are table-top vacuum steam sterilizers designed to process medical and dental instruments to achieve successful sterilization. The units utilize saturated steam at high pressures and temperatures to attain an effective kill of infectious bio-organisms.
BRAVO autoclaves are equipped with either a 17 or 21 litre sterilization chamber and feature an advanced fractionated vacuum system to achieve complete air removal from the sterilization chamber and effective final vacuum drying with an effective final vacuum to minimize the presence of condensation from the finished load.
Instruments are placed onto a sterilization tray which is then inserted into the sterilization chamber and the unit is closed. One of the ten pre-set sterilization cycles is selected and the unit is started. The units are fully automatic for the complete sterilizing cycle.
An exclusive steam generation system, combined with an advanced control system, guarantees optimal thermodynamic parameters during the entire sterilization process.
The devices offer sterilization programs optimized for the effective and fast sterilization of various instruments and materials used in the medical and dental environments. Depending on the preset cycle chosen, the devices will progress through a series of pulses which consist of one to three vacuum draws followed by pressurization to create steam in order to remove any air from the sterilization chamber. They will then maintain the projected sterilization time, vent down to atmospheric conditions and begin a heated vacuum dry cycle that will run for a predetermined period of time depending on the model as well as the cycle selected. The devices then return to atmospheric conditions so that the door can be opened to remove the processed load.
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K Number
K073319Device Name
STATMATIC 31 HANDPIECE MAINTENANCE UNIT
Manufacturer
SCICAN LTD.
Date Cleared
2008-02-04
(70 days)
Product Code
EFB
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
SCICAN LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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