# K101054: Romiapex Model a-15

- Pathway: 510(k) (Traditional)
- Applicant: Romidan, Ltd.
- Decided: Sep 3, 2010 after 141 days
- Product code: LQY (Locator, Root Apex)
- Device class: U
- 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 K992233 (1999). 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)
- K992233: Apex Locator Bingo-1020, Dent Corp. Research & Development (1999) Summary page 5.

## Indications for use
RomiAPEX™ A-15 is indicated for patients who need to undergo root canal treatment, which requires precise determination of position of the dental file in the canal relatively to the root apex.

Source page: https://510kreport.com/device/K101054
Methodology: https://510kreport.com/methodology