# K962031: Quantec Series 2000 Endodontic Files

- Pathway: 510(k) (Traditional)
- Applicant: Tycom Dental
- Decided: Jun 4, 1996 after 11 days
- Product code: EKS (File, Pulp Canal, Endodontic)
- Device class: 1
- Regulation: 21 CFR 872.4565
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K933582 (1993). 2 ancestors in all.
249 later devices descend from it; 3 cite it directly.
0 of 252 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933582: Profile Series 29 Files, Tulsa Dental Products, Ltd. (1993) Summary page 1.
- K943584: Presterilized Endodontic Files, Dentsply Intl. (1994) Summary page 1.

## Most influential descendants
- 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
- K073063: 15W Ceralas D 1470NM Diode Laser (2008), 202 descendants of its own

## Indications for use
The Quantec Series 2000 Endodontic Files are designed for use in root canal preparation.

Source page: https://510kreport.com/device/K962031
Methodology: https://510kreport.com/methodology