# K071278: Embrace Dual Cure Composite Materials

- Pathway: 510(k) (Traditional)
- Applicant: Pulpdent Corporation
- Decided: Jun 29, 2007 after 53 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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) Pulpdent Embrace Resin Cement: named in the summary without a submission number
- (no number) Pulpdent Embrace WetBond Pit and Fissure Sealant: named in the summary without a submission number
- (no number) Pulpdent ResiLute Resin Cement: named in the summary without a submission number
- (no number) Pulpdent VLC Resin Cement: named in the summary without a submission number
- (no number) Pulpdent Embrace WetBond Restorative Materials: named in the summary without a submission number
- (no number) Apex Dental Materials anchor®: named in the summary without a submission number
- (no number) Den-Mat Core Paste XP: named in the summary without a submission number

## Most influential descendants
- K113617: Spee-Dee Patch (2012), 0 descendants of its own

## Indications for use
Embrace rMDual Cure Composite Materials are multi-purpose, hydrophilic, fluoride-releasing, resin-based materials that contain no Bisphenol A and bond tightly to dentition. Embrace rM Dual Cure Composite Materials are used to permanently cement dental posts, porcelain crowns, inlays, onlays, bridges, porcelain/laminate veneers and periodontal splints, to repair porcelain crowns intra-orally and as a build-up and repair material.

Source page: https://510kreport.com/device/K071278
Methodology: https://510kreport.com/methodology