# K971065: Dentica Pulsed ND: Yag Laser Systems and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Xintec Corporation
- Decided: Jun 17, 1997 after 85 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K182930: PerioLase Nd:YAG Pulsed Dental Laser System (2019), 0 descendants of its own

## Indications for use
The Dentica Pulsed Nd:YAG Laser System and accessories is indicated for incision/excision, ablation, and coagulation (homeostasis) of soft tissue and cartildge. Soft tissue which may be encountered in surgical procedure includes skin, subcutaneous tissue, striated and smooth muscle, cartilage, mucous membrane, lymph vessels and nodes, organs and glands. Specific surgical specialties include: Dentistry Laser Curettage; Gingivectomy; Gingivoplasty; Incision and Excision Oral Surgery Frenectomy; Incisional and Excisional Biopsy; Incisional and Excisional aphous ulcers; Incision of infection when used with antibiotic therapy; Excision and ablation of benign and malignant lesions and conditions; Homeostasis; Operculectomy, and Crown lengthening. Ear Nose & Throat (ENT) Head and Neck Surgery Thoracic Surgery Neurology (homeostasis only) Dermatology Plastic Surgery General Surgery

Source page: https://510kreport.com/device/K971065
Methodology: https://510kreport.com/methodology