# K022351: Diodent Dental Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Continuum Electro-Optics, Inc.
- Decided: Oct 16, 2002 after 89 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) TwiLite/TwiLiteWhite: named in the summary without a submission number
- (no number) Ceralas Model D15: named in the summary without a submission number
- (no number) Opus 10: named in the summary without a submission number

## Most influential descendants
- K031819: Dio-Dent 10 Dental Diode Laser (2003), 0 descendants of its own

## Indications for use
1. Light activation for bleaching materials for teeth whitening. 2. Laser-assisted bleaching/whitening for teeth.

Source page: https://510kreport.com/device/K022351
Methodology: https://510kreport.com/methodology