# K133412: S200, S300

- Pathway: 510(k) (Traditional)
- Applicant: Cefla S.C.
- Decided: Jan 8, 2015 after 427 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The dental device is composed by two distinguished and physically connected equipments, that are: - dental chair - dental unit (hydro-group) The dental chair is an equipment whose function is to support and position the patient during the dental operations. The dental unit is an equipment connected to the dental chair whose function is to lodge, support and functionally supply the professional instruments used by the dentist and it is combined with accessories. The dental device is composed by two distinguished and physically connected equipments, that are: - dental chair - dental unit (hydro-group) The dental chair is an equipment whose function is to support and position the patient during the dental operations. The dental unit is an equipment connected to the dental chair whose function is to lodge, support and functionally supply the professional instruments used by the dentist and it is combined with accessories.

Source page: https://510kreport.com/device/K133412
Methodology: https://510kreport.com/methodology