# K031877: Embrace Wet-Bond Restorative Material

- Pathway: 510(k) (Traditional)
- Applicant: Pulpdent Corporation
- Decided: Aug 1, 2003 after 45 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 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 Pit and Fissure Sealant: named in the summary without a submission number
- (no number) Ivoclar Tetric Flow: named in the summary without a submission number
- (no number) Ivoclar Compoglass Flow: named in the summary without a submission number
- (no number) Kuraray Clear-Fil: named in the summary without a submission number
- (no number) Kerr OptiBond Solo Plus 3: named in the summary without a submission number

## Most influential descendants
- K072545: Artiste SE Flowable Composite, Model N280 (2007), 2 descendants of its own
- K102603: SA Flowable Adhesive (2010), 1 descendant of its own
- K231263: Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT (2024), 0 descendants of its own

## Indications for use
Embrace Wet-Bond Restorative Material is a hydrophilic, fluoride-releasing, light-cured material recommended for use as a tooth replacement material. Applications of Embrace Wet-Bond Restorative Material include: Class I, Ill, IV, and V cavity preparations and as a restorative material for small incipient lesions.

Source page: https://510kreport.com/device/K031877
Methodology: https://510kreport.com/methodology