# K092917: Stern's S250 Nordam

- Pathway: 510(k) (Abbreviated)
- Applicant: Cefla S.C.
- Decided: Jun 24, 2010 after 275 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 Continental version can be identified by an instmuments table type S.P.R.I.D.O. In this type of table a rod device supports the cord during the activation and the rest of the instrument. The International version can be identified by an instruments table with pending cords. In this type of table resting instruments are hold in specific housings that support them in an almost vertical position, while the cord is pending from the instruments table. The dental device is used by dentist in order to perform dental operations in the dentist's surgery. During the practice and use of the dental device, the dentist can be helped by an assistant who can use some instruments of the dental unit.

Source page: https://510kreport.com/device/K092917
Methodology: https://510kreport.com/methodology