# K974057: Dentek LD 15 Lasersystem

- Pathway: 510(k) (Traditional)
- Applicant: Dentek Lasersystems Produktions Ges.M.B.H.
- Decided: Apr 21, 1998 after 176 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.
281 later devices descend from it; 1 cites it directly.
0 of 282 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
- K991994: Twilight (1999), 280 descendants of its own
- K012511: Waterlase Millennium (2002), 246 descendants of its own
- K021508: Opusduo EC Dental Laser System (2002), 240 descendants of its own
- K040270: Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus Spectrum (2004), 226 descendants of its own
- K060033: Profile Multi-Platform System (2006), 221 descendants of its own

## Indications for use
- Soft Tissue . gingivectomy . gingival incisions and excisions . tissue retraction for impressions . frenectomy— . treatment of aphthous ulcers . excisional and incisional biopsies . Incising and draining of abscesses . exposure of unerupted teeth . hemostasis

Source page: https://510kreport.com/device/K974057
Methodology: https://510kreport.com/methodology