# K990680: Dentec LD 15 Diode Laser

- Pathway: 510(k) (Traditional)
- Applicant: Dentek Lasersystems Produktions Ges.M.B.H.
- Decided: Jul 30, 1999 after 150 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.
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 DENTEK LD 15 LaserSystem is intended for use for incision, excision, vaporization, ablation, coagulation in oral soft tissue, for removal of diseased or inflamed soft tissue in the periodontal pocket and to perform pulpotomy and pulpotomy as adjunct to root canal therapy. - Endodontology / Pulpotomy and pulpotomy as adjunct to rootcanal therapy - Periodontology / Removal of diseased or inflamed soft tissue in the periodontal pocket ( sulcular debridement ) ~ Soft Tissue Gingivectomy, Gingival incision and excisionTissue retraction for impressions, Frenectomy, Treatment of aphtous ulcers, Excisional and incisional biopsies, Incising and draining of abscesses, Exposure of unerupted teeth, Hemostasis

Source page: https://510kreport.com/device/K990680
Methodology: https://510kreport.com/methodology