# K132245: Ajax Dental Unit

- Pathway: 510(k) (Traditional)
- Applicant: Pro Dental Services, LLC
- Decided: Sep 5, 2014 after 414 days
- Product code: EIA (Unit, Operative Dental)
- Device class: 1
- Regulation: 21 CFR 872.6640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K962071 (1996). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102234: A-Dec 200 Dental System, A-Dec, Inc. (2010) Summary page 4.
- K080438: Dental Unit with Chair, North West Medical Instrument (Group) Co., Ltd. (2008) Summary page 4.

## Indications for 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.

Source page: https://510kreport.com/device/K132245
Methodology: https://510kreport.com/methodology