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510(k) Data Aggregation
K Number
K073284Device Name
AIR-FLOW MASTER STANDARD
Manufacturer
(EMS SA) ELECTRO MEDICAL SYSTEMS
Date Cleared
2007-12-14
(23 days)
Product Code
EFB, KOJ
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
(EMS SA) ELECTRO MEDICAL SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AIR-FLOW MASTER STANDARD is an air-polishing unit intended for use in the cleaning and polishing of teeth by the projection of water, air, and dental powders onto the tooth surface. The device removes dental plaque, soft deposits, and surface stains from pits, grooves, interproximal spaces, or smooth surfaces of teeth.
The device can also be used for the following cleaning procedures:
- plaque removal for placement of sealants
- surface preparation prior to bonding/cementation of inlays, onlays, crowns and veneers
- surface preparation prior to placing composite restorations
- effective plaque and stain removal for orthodontic patients
- cleaning prior to bonding ortho brackets
- cleaning implant fixture prior to loading
- stain removal for shade determination
- plaque removal prior to fluoride treatment
- plaque and stain removal prior to whitening procedure
Device Description
The AIR-FLOW MASTER STANDARD is an air-polishing unit containing an operating unit, air/water pressure powered handpiece cords, powder chambers, AIR-FLOW handpieces, prophylaxis powders, multifunction footpedal and connections for external water and air supply. The operating unit of the AIR-FLOW MASTER STANDARD regulates the water and air/powder flow and selection of the prophylaxis powder chamber (Working Mode). The multifunction footpedal controls the operation of the AIR-FLOW handpieces. Upon installation, the AIR-FLOW MASTER STANDARD operating unit is connected to the external water and air supply.
Prior to use, the prophylaxis powder is loaded into the powder chamber and the chamber fixed to the operating unit. The AIR-FLOW handpiece is inserted into the air pressure powered handpiece cord and a powder nozzle is attached to the end of the AIR-FLOW handpiece. The operating unit is switched on and the air/powder flow and the Working Mode are adjusted on the control panel. When the operating unit is switched on, the powder chambers are under pressure. Air enters the powder chamber of the operating unit where it mixes with the prophylaxis powder. The air/powder mixture leaves the powder chamber and enters the handpiece cord. When the multifunction footpedal is pressed, the air pressure of the handpiece cord is activated and allows the air/powder mixture to be delivered to the AIR-FLOW handpiece for treatment. The air/powder mixture exits the distal end of the AIR-FLOW handpiece through the powder nozzle where it is enveloped by a water spray and directed onto the tooth surface.
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K Number
K032099Device Name
SWISS MASTER LIGHT
Manufacturer
(EMS SA) ELECTRO MEDICAL SYSTEMS
Date Cleared
2003-10-27
(111 days)
Product Code
EBZ
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
(EMS SA) ELECTRO MEDICAL SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Swiss Master Light® is a dental curing light that is designed for use in the photopolymerization of dental resins, activation of tooth whitening agents in bleaching procedures.
Device Description
The Swiss Master Light® consists of a control unit with a handpiece connected to the Main Unit by a detachable handpiece cord. The handpiece contains the halogen light source and a light guide that directs light to the treatment area on the patient. The control unit provides power and cooling water to the handpiece and controls handpiece function.
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K Number
K992504Device Name
EMS KERMIT
Manufacturer
(EMS SA) ELECTRO MEDICAL SYSTEMS
Date Cleared
2000-01-27
(184 days)
Product Code
ELC
Regulation Number
872.4850Why did this record match?
Applicant Name (Manufacturer) :
(EMS SA) ELECTRO MEDICAL SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EMS KERMIT® is an ultrasonic scaler which is intended for the following:
- Removing supra and subgingival calculus deposits and stains from the teeth
- Periodontal pocket lavage with simultaneous ultrasonic tip movement
- Scaling and root planing
- Releasing crowns, bridges, inlays and posts as well as condensing gutta percha
- Plugging for amalgam condensation
- Amalgam burnishing
- Preparing, cleaning, and irrigating root canals
- Preparing approximal cavities
- Cementing inlays and onlays
- Retrograde preparation of root canals
Device Description
Ultrasonic Scaler
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K Number
K991874Device Name
EMS SURFACE MOUNT SCALER
Manufacturer
(EMS SA) ELECTRO MEDICAL SYSTEMS
Date Cleared
1999-07-30
(58 days)
Product Code
ELC
Regulation Number
872.4850Why did this record match?
Applicant Name (Manufacturer) :
(EMS SA) ELECTRO MEDICAL SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EMS Surface Mount Scaler is an ultrasonic scaler and is intended for the removal of supra and subgingival calculus deposits and stains from the teeth; periodontal pocket lavage with simultaneous ultrasonic tip movement; and scaling and root planing.
Device Description
The EMS Surface Mount Scaler consists of a control unit housing containing the ultrasonic generator, a dental handpiece, scaler instrument, and torque wrench. The Scaler is designed to operate in conjunction with the office dental unit. The control unit housing is mounted under the control head of the dental unit and is connected to the water supply, hanger air supply, pneumatic foot switch, and electrical supply of the dental unit. The Scaler ultrasonic power and water flow are simultaneously activated by pressing the dental unit foot switch. Power output and water flow can be adjusted using the knobs on the front of the Scaler. The Scaler handpiece is designed to be placed in the dental unit's handpiece hanger when not in use.
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K Number
K991588Device Name
EMS SWISS ORTHOCLAST
Manufacturer
(EMS SA) ELECTRO MEDICAL SYSTEMS
Date Cleared
1999-07-21
(75 days)
Product Code
HSZ, GET, LZV
Regulation Number
878.4820Why did this record match?
Applicant Name (Manufacturer) :
(EMS SA) ELECTRO MEDICAL SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Swiss OrthoClast® is used for the removal of bone cement during implant revision surgery.
Device Description
The EMS Swiss OrthoClast® system consists of a pressure regulator/control unit, pneumatic footswitch, handpiece, chisels of various sizes and shapes, a hollow drill and extractor for removal of the cement tip, and the Orthoscope. The Swiss OrthoClast® uses simple pneumatic and ballistic principles to fragment bone cement. A pressure pulse generated by the pressure regulator/control unit causes a moveable projectile in the handpiece to be driven forward to strike the proximal end of the chisel. The impact generates a shock wave along the chisel, which leads to a small, high-speed excursion of the chisel tip. The distal end of the chisel is held in contact with the targeted cement. Repetitive shock waves result in fragmentation of the bone cement. A short tip excursion period followed by a longer rest period prevents the build-up of heat in the fragmentation site. Direct vision into body cavities, such as the femoral cavity, is facilitated using the Orthoscope.
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