# K122748: Engler 25K Series Ultrasonic Inserts

- Pathway: 510(k) (Traditional)
- Applicant: Engler Engineering Corp.
- Decided: Jun 11, 2013 after 277 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
This product will be used by Dental professionals and authorized technicians to clean teeth by means of ultrasonic scaling. It can be placed into any approved 25K Ultrasonic Dental device handpiece on the market. This devices is for Prescription Use as established by 21 CFR Part 801 Subpart D and it will be sold to the practitioner or through an authorized distributor.

Source page: https://510kreport.com/device/K122748
Methodology: https://510kreport.com/methodology