# K082434: GDLS-200

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: Nov 14, 2008 after 81 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
No predicates in its family tree.
44 later devices descend from it; 5 cite it directly.
0 of 45 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
- K091388: GCUC-505 (2009), 43 descendants of its own
- K123631: MFP-051 (2013), 39 descendants of its own
- K133824: Cerasmart (2014), 32 descendants of its own
- K160425: CAD/CAMouflage Milling Bock (2016), 26 descendants of its own
- K162537: CAD/CAMouflage Milling Block (2016), 25 descendants of its own

## Indications for use
GDLS is a light-cured micro-filled radiopaque composite resin for the restoration of both anterior and posterior teeth. GDLS-200 consists of two delivery systems, Unitip (capsules for single dose) and Syringes. The GDLS-200 systems is available in a variety of shades.

Source page: https://510kreport.com/device/K082434
Methodology: https://510kreport.com/methodology