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510(k) Data Aggregation
K Number
K112623Device Name
AIRLIGHT DENTAL HANDPIECE
Manufacturer
Date Cleared
2011-12-16
(99 days)
Product Code
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
BEYES DENTAL CANADA INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Airlight Dental Handpiece Series, models M600 and M800 are intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.
Device Description
The Airlight Dental Handpiece is a high speed dental handpiece with a lightly textured finish for enhanced grip. It is a hand-held, channeled instnument that is powered by compressed air that is delivered through a hose to an air channel is the handpiece. This impels the turbine in the head of the handpiece to nevolve in Other internal channels deliver air and water to the head for cleaning and cooling. Any common dental bur is held in place in the handpiece head by a push-buttong There are three major parts which are made metal: a standard turbine, the threaded connector at the back end which attaches to the standard air/water hose in the dental unit, and the internal tubes that carry the chip air and water. The new three parts are substantially equivalent to those in the predicate device. Similar to the predicate device, the Airlight Dental Handpiece must be cleaned and lubricated with a quality commercial dental handpiece cleaner/lubricant. It is supplied non-sterile, but must be sterilized before use, as with the predicate device. It will be packaged as a single unit or in multiples.
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K Number
K112869Device Name
EASYPROPHY SERIES AIR POLISH DEVICES, MODELS EASYPROPHY 200 AND EASYPROPHY 400
Manufacturer
Date Cleared
2011-12-16
(77 days)
Product Code
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
BEYES DENTAL CANADA INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The EasyProphy Series Air Polish Devices are intended for use in dental applications to remove stains and plaque deposits from the teeth by shooting a mixture of sodium bicarbonate powers, air, and water onto tooth surfaces.
Device Description
This device is a hand-held device that contains air and water lines, a capped chamber for the cleaning powder, and a nozzle. This device connects to a standard turbine tube that supplies air and water. When the Air Polisher is connected and activated, a stream comprised of powder, air, and water sprav is generated. This spray can be directed on the tooth surface to clean and polish the tooth.
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