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510(k) Data Aggregation
K Number
K991857Device Name
AIRFLOW HANDY
Manufacturer
ELECTRO MEDICAL SYSTEMS, INC.
Date Cleared
1999-10-07
(128 days)
Product Code
EFB
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
ELECTRO MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AirFlow handy is a dental handpiece intended for use in the cleaning and polishing of teeth by the projection of water, air, and bicarbonate powder onto the tooth surface. The device removes soft deposits and areas of discoloration and can be used to clean teeth prior to dental procedures which require a clean tooth surface such as the placement of composite fillings, inlays, and laminate veneers.
The device can also be used to clean the following:
- implant abutments and teeth prior to treatments such as shade matching, fluoridation, and bleaching
- crowns and bridges
- fixed bands and brackets prior to placement on orthodontic appliances.
Device Description
The AirFlow handy is a hand-held device containing air and water lines, powder chamber with cap, and AirFlow nozzle. The device connects to a standard turbine tube which supplies air and water. When the AirFlow handy is connected to the turbine tube and the turbine is activated, an air/powder stream enveloped by a water spray is generated which can be directed onto the tooth surface for cleaning and polishing.
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K Number
K965203Device Name
RADX SYSTEM
Manufacturer
ELECTRO MEDICAL SYSTEMS, INC.
Date Cleared
1997-03-17
(81 days)
Product Code
EHD
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
ELECTRO MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RAD& System digitizes and processes dental radiographs to perform longitudinal radiographic analysis using the digital subtraction technique. This technique is helpful in the detection of hard tissue changes including pathologies as well as resolution of those same pathologies.
Device Description
The RAD System enables the dental practitioner to take a longitudinal series of X-rays using the long-cone paralleling technique, digitize the resulting images, and perform digital subtraction analysis to detect very small changes in bone densities. The RAD System consists of a high resolution digital image scanner and the RADy software program. Also required are an IBM compatible personal computer, a long cone, and a parallel aiming system. The ability of the RADx System to create spatially registered images for comparison without the use of rigid projection geometry allows longitudinal radiographic analysis using equipment readily available to the average dental practitioner.
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