# K113617: Spee-Dee Patch

- Pathway: 510(k) (Traditional)
- Applicant: Pulpdent Corporation
- Decided: Mar 2, 2012 after 86 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 K882006 (1988). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071278: Embrace Dual Cure Composite Materials, Pulpdent Corporation (2007) Summary page 1.
- K020287: Dentition Integrating Material, Pulpdent Corporation (2002) Summary page 1.
- K882006: Clearfil Photo Core, Kuraray Co. (1988) Summary page 1.

## Indications for use
Spee-Dee Patch is a visible light cured, glass-filled resin that is intended as a vital tooth build-up material where restorations were removed and must be built up for crown preparation; as a non-vital tooth post and core; as a build up material; and as a repair material to repair fractured cusps, lost partial or whole fillings, chipped crowns, broken teeth, crowns, or bridges.

Source page: https://510kreport.com/device/K113617
Methodology: https://510kreport.com/methodology