# K011839: Doxadent Dental Composite, Models a, B, C, 12A, 12B, 12C, 6A, 6B, and 6C

- Pathway: 510(k) (Traditional)
- Applicant: Doxa Certex AB
- Decided: Jan 17, 2002 after 219 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Dentsply AP Dyract® Compomer: named in the summary without a submission number
- (no number) Bisco, Inc.’s PYRAMID™ dental composite: named in the summary without a submission number
- (no number) Bisco, Inc.’s ADVENT™ dental composite: named in the summary without a submission number
- (no number) Bisco, Inc.’s RENEW™ dental composite: named in the summary without a submission number
- (no number) Colténe/Whaledent’s Coltosol Temporary Endodontic Filling: named in the summary without a submission number

## Most influential descendants
- K081405: Xeracem (2008), 1 descendant of its own
- K100510: Ceramir Crown & Bridge (2010), 0 descendants of its own

## Indications for use
DoxaDent is a dental ceramic composed of calcium aluminate cement and oxides that is intended to restore carious lesions or structural defects in teeth. Specifically, DoxaDent is indicated for use as a restorative dental material for permanent application in the treatment of class I, I, and V cavities.

Source page: https://510kreport.com/device/K011839
Methodology: https://510kreport.com/methodology