# K180935: Infinity / Infinity Cross Flex Dental Systems

- Pathway: 510(k) (Traditional)
- Applicant: Olsen Industria E Comercio S.A.
- Decided: Feb 5, 2020 after 666 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K213742: Infinity Pro, Logic, Quality, Sprint (2022), 0 descendants of its own

## Indications for use
Infinity / Infinity Cross Flex Dental Systems are intended for use in general dental applications by providing the dental practitioner a user interface to control operation of the dental chair and attached dental devices. The, system delivers air, water and vacuum to allow the dental practitioner an intuitive control center for all common and normal patient treatment procedures performed by the dentist / dental assistant.

Source page: https://510kreport.com/device/K180935
Methodology: https://510kreport.com/methodology