# K123139: Advanced Endodontic System- Designer Series

- Pathway: 510(k) (Traditional)
- Applicant: Asi Medical, Inc.
- Decided: Mar 28, 2013 after 174 days
- Product code: ELC (Scaler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 872.4850
- 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 ASI 'Advanced Endodontic System - Designer Series (Models 2133E, 2i134E, 2115E, 2125E)' is a self-contained dental treatment unit that contains a built in air compressor, vacuum system arid water supply. It is designed to provide air, water, vacuum and electricity to operate various dental handpieces, accessories and attachments and to serve as a base for other dental devices and accessories. The device is intended for use to provide general dental restorative care and hygiene procedures in both traditional dental office settings and/or mobile applications by or under the supervision of a licensed dentist or a hygienist if permitted by applicable law

Source page: https://510kreport.com/device/K123139
Methodology: https://510kreport.com/methodology