# K982318: Spectrum 800 Curing Unit

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: Sep 15, 1998 after 75 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- 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 K951425 (1995). 1 ancestor in all.
16 later devices descend from it; 4 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951425: Spectrum Curing Light Polymerization Unit, Dentsply Intl. (1995) Summary page 1.

## Most influential descendants
- K031615: Sled Curing Light System (2003), 13 descendants of its own
- K041372: Smartlite PS Pen-Style Led Curing Light (2004), 12 descendants of its own
- K063529: Pencure, Model VL-7 (2007), 7 descendants of its own
- K071190: Root ZX II (2007), 6 descendants of its own
- K090925: Multiple (Apex Locator), Model RCM-7 (2009), 2 descendants of its own

## Indications for use
The SPECTRUM™ 800 CURING UNIT provides visible light irradiation for the curing of dental VLC resin products.

Source page: https://510kreport.com/device/K982318
Methodology: https://510kreport.com/methodology