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510(k) Data Aggregation
K Number
K132245Device Name
AJAX DENTAL UNIT
Manufacturer
Date Cleared
2014-09-05
(414 days)
Product Code
Regulation Number
872.6640Why did this record match?
Applicant Name (Manufacturer) :
PRO DENTAL SERVICES LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The dental chair is used so that the patient at the dentist office may sit on it while the dentist is performing diagnosis, treatment, and/or operation. The dental unit consists of patient chair, dentist element, assistant element, water unit, arm system, cuspidor unit, and dental light. The Dental Unit with Chair is intended to supply power to and serve as a base for dental devices and accessories. It is intended for use in the dental clinic/office environment and used by trained dentists and/or dental technicians and assistants. This product is attached with a dental chair.
Device Description
Ajax Dental Unit AJ1X is a dental operative unit attached to a chair. It consists of a patient chair, dentist element, assistant element, water unit, arm system, cuspidor unit, and dental light. The AJ1X unit is specially designed to meet the needs of dental professionals. The concept of hygienic treatment is emphasized in the unit design. Components are designed in the way which dentist can easily maintain and clean. Concept of the unit is to optimize the work for dental practice, as well as provide a very clean and healthy treatment environment for both dentists and patients.
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