# K150490: UnicLine Mobile

- Pathway: 510(k) (Traditional)
- Applicant: Heka Dental A/S
- Decided: Apr 17, 2015 after 51 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: 1 generation back to K101332 (2011). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101332: Amc-20 Portable Dental Cart Model Amc-20, Aseptico, Inc. (2011) Summary page 4.

## Indications for use
The UNICLINE MOBILE is an electrically powered, self-contained mobile dental operative unit intended to supply power to and serve as a base for other dental devices and instruments. The system is indicated for performing general dental procedures. The device is intended for operation and use in a clinical setting by legally qualified professionals.

Source page: https://510kreport.com/device/K150490
Methodology: https://510kreport.com/methodology