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510(k) Data Aggregation
K Number
K190124Device Name
EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One
Manufacturer
Date Cleared
2019-10-20
(268 days)
Regulation Number
872.4850Why did this record match?
Applicant Name (Manufacturer) :
E.M.S Electro Medical Systems S.A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The AIRFLOW Prophylaxis Master combines the functions of an ultrasonic scaler and air-polishing unit within a single chassis. The AIRFLOW Prophylaxis Master is intended for use in the following dental applications:
- · Removing supra and subgingival calculus deposits and stains from 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
- · Cavity preparation
- · Cementing inlays and onlays
- · Retrograde preparation of root canals
The AIRFLOW Prophylaxis Master is 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 AIRFLOW Prophylaxis Master can 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
The AIRFLOW Prophylaxis Master is also intended for use as an air-polisher in patients suffering from periodontal disease. The AIRFLOW Prophylaxis Master is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.
The AIRFLOW One is 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 AIRFLOW One can be used for the following cleaning procedures:
- · plaque removal for placement of sealants
- · surface preparation prior to bonding/cementation of inlays, 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
The AIRFLOW One is also intended for use as an air-polisher in patients suffering from periodontal disease. The AIRFLOW One is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.
Device Description
The EMS AIRFLOW Prophylaxis Master is a dental device that combines the functions of an ultrasonic scaler and air-polishing unit within a single chassis. The proposed device consists of a control unit, hoses, handpiece cords for the two handpieces and a foot pedal which can be wired or wireless. There are two repositories on the control unit: one for the irrigation liquid container or the waterline cleaner container and the other one for one of both air-polishing powder chambers supplied with the device.
The AIRFLOW Prophylaxis Master is supplied with the Piezon Handpiece LED for performing ultrasonic scaling functions. The proposed device is compatible with EMS instruments legally marketed for ultrasonic scaling procedures.
The AIRFLOW Prophylaxis Master is also supplied with the AIR-FLOW Handpiece and optionally with the PERIO-FLOW Handpiece and the PERIO-FLOW Nozzles marked for performing air-polishing procedures. The proposed device is compatible with the AIR-FLOW CLASSIC new formula (sodium bicarbonate), AIR-FLOW SOFT (glycine), AIR-FLOW PERIO (glycine) and AIR-FLOW PLUS (Erythritol) prophylaxis powders.
The AIRFLOW Prophylaxis Master is supplied with accessories for attaching and removing instruments and nozzles from the handpieces.
The EMS AIRFLOW One is the same device as the EMS AIRFLOW Prophylaxis Master without the ultrasonic scaling function. Therefore, the description of the AIRFLOW Prophylaxis Master is also applicable to the AIRFLOW One, except the part related to the ultrasonic scaling function.
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K Number
K191079Device Name
Piezon Built-in Kit, Piezon Built-in Kit LED
Manufacturer
Date Cleared
2019-08-16
(115 days)
Product Code
Regulation Number
872.4850Why did this record match?
Applicant Name (Manufacturer) :
E.M.S Electro Medical Systems S.A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Scaling:
- Removal of supragingival and subgingival calculus
- Removal of stains
Device Description
The proposed devices, PIEZON BUILT-IN KIT and the PIEZON BUILT-IN KIT LED, represent a change in presentation from the stand alone PIEZON 150 (predicate) to a device which is built in to the dental chair (OSSTEM K3 (K152830) ). The proposed device and the predicate device are both manufactured using the same internal componentry, the only difference is that instead of housing the device for stand alone use, the componentry is installed into a dental chair.
The difference between PIEZON® BUILT-IN KIT LED and PIEZON® BUILT-IN KIT is that the handpiece of the first features integrated light (LED) while the second does not. All other aspects are identical. Each system consists of the wireless module and handpiece cord and is provided with a wire harness for installation as well as the appropriate accessories. Additionally, spare parts are available.
As with other ultrasonic scalers, the ultrasonic generator component of the PIEZON BUILT-IN KIT and PIEZON BUILT-IN KIT LED (Piezon® Module EJ-110, installed in a dental chair) generates piezo-electric vibrations (ultrasonics) for water or dry work instruments. The PIEZON BUILT-IN KIT and PIEZON BUILT-IN KIT LED are supplied with the Piezon Handpiece EN-061/OS and Piezon Handpiece LED EN-060/OS, respectively. Instruments mounted in the Piezon Handpiece or Piezon Handpiece LED vibrates with a controlled oscillatory movement when activated.
Instruments A is supplied as part of all kits. Instruments P and PS are additionally included in the kits with OS1 suffix. The appropriate instrument for the particular application is screwed onto the handpiece prior to beginning the procedure. The treatment is carried out by placing the instrument tip onto the tooth surface according to the Operating Instruction for the instrument selected.
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