# K031421: Ultrasonic Scaler, Models Varios 350 Lux, Varios 350 (NO Light), Varios 550, Varios 150 Lux, Varios 150 (NO Light)

- Pathway: 510(k) (Traditional)
- Applicant: Nakanishi, Inc.
- Decided: Mar 26, 2004 after 326 days
- Product code: ELC (Scaler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 872.4850
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices 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.

## Most influential descendants
- K113717: Ultrasonic Scaler (2013), 0 descendants of its own
- K070975: Symmetry IQ, Model 2000 Series, 3000 Series (2007), 0 descendants of its own
- K070866: Asc-12 Piezoelectric Scaler (2007), 0 descendants of its own

## Recalls of this device
- Jul 8, 2016 · Class II · Z-2672-2016: Through an error, the labeling failed to include the symbol or other text indicating that the diamond coated tips were single use only. A contributing factor to this error is that in other markets suc

## Indications for use
These devices are ultrasonic scalers, intended for use with an appropriate tip for scaling, crown removal, amalgam condensation, excavating, periodontal, and endodontic use.

Source page: https://510kreport.com/device/K031421
Methodology: https://510kreport.com/methodology