# K082325: Apexum Ablator

- Pathway: 510(k) (Traditional)
- Applicant: Apexum, Ltd.
- Decided: Apr 21, 2009 after 250 days
- Product code: EKX (Handpiece, Direct Drive, Ac-Powered)
- Device class: 1
- Regulation: 21 CFR 872.4200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K951607 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971603: Sterile Sureflex Files and Instruments, Dentsply Intl. (1997) Summary page 1.
- K062856: TF Rotary Nickel Titanium File, Ormco Corp. (2006) Summary page 1.
- K004031: NT Swift; TI\Tec; Gates Glidden Drills; Dental Power Endodontic Hand Files, Dental Power, Inc. (2001) Summary page 1.
- K920978: Ula (Poliglecaprone 251) Synthetic Absor Sut, Dyed, ETHICON, Inc. (1994) Summary page 1.

## Indications for use
Removal of necrotic or inflamed tissue from the apical foramen and periapical region during root canal treatment.

Source page: https://510kreport.com/device/K082325
Methodology: https://510kreport.com/methodology