# K113818: Embrace Wetbond Pit and Fissure Sealant, Low Fill

- Pathway: 510(k) (Traditional)
- Applicant: Pulpdent Corporation
- Decided: Mar 21, 2012 after 85 days
- Product code: EBC (Sealant, Pit And Fissure, And Conditioner)
- Device class: 2
- Regulation: 21 CFR 872.3765
- 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 K020287 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020287: Dentition Integrating Material, Pulpdent Corporation (2002) Summary page 1.
- K052281: Embrace Wetbond Clear Sealant, Pulpdent Corporation (2006) Summary page 1.

## Indications for use
Embrace Pit and Fissure Sealant Low Fill is a professional dental material, designed with no Bisphenol A, that contains fluoride releasing, light cured, glass-filled acrylate resins and is less than 10% filled. Embrace Pit and Fissure Sealant, Low Fill is available in two shades (tooth-colored and off-white) and is used to seal the pits and fissures in teeth.

Source page: https://510kreport.com/device/K113818
Methodology: https://510kreport.com/methodology