# K052281: Embrace Wetbond Clear Sealant

- Pathway: 510(k) (Traditional)
- Applicant: Pulpdent Corporation
- Decided: Feb 8, 2006 after 170 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
No predicates in its family tree.
7 later devices descend from it; 3 cite it directly.
0 of 8 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) Pulpdent Embrace Seal-n-Shine: named in the summary without a submission number
- (no number) Dentsply Delton Clear: named in the summary without a submission number
- (no number) Bisco BisCover: named in the summary without a submission number
- (no number) Cosmedent CosmeSeal: named in the summary without a submission number

## Most influential descendants
- K073395: Gilb-2, Glass Ionomer Protective Coating (2008), 3 descendants of its own
- K091632: SPK Sealant (2009), 2 descendants of its own
- K112517: Ultraseal XT Hydro (2011), 1 descendant of its own
- K100062: Infiltration Kit (2010), 1 descendant of its own
- K251124: G-Bond Universal (2025), 0 descendants of its own

## Indications for use
EmbraceTM WetBond TM Clear Sealant is a hydrophilic, light-cured material recommended for use as a pit and fissure sealant. EmbraceTM WetBondTM Clear Sealant may be used to seal small defects such as buccal pits, lingual grooves or facial surface defects. EmbraceTM WetBondTM Clear Sealant may also be used as an orthodontic bracket coating. EmbraceTM WetBondTM Clear Sealant hardens/cures such that the material is clear.

Source page: https://510kreport.com/device/K052281
Methodology: https://510kreport.com/methodology