# K093019: Enamelite Acryseal Spray Sealant

- Pathway: 510(k) (Traditional)
- Applicant: Enamelite, LLC
- Decided: Dec 22, 2009 after 84 days
- Product code: EBD (Coating, Filling Material, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K945604 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081981: Lang Dental Acrylic Primer, Lang Dental Mfg. Co., Inc. (2008)
- K892452: Palaseal (R), Kulzer, Inc. (1989) Summary page 2.
- K061981: Surpass, Apex Dental Materials, Inc. (2006) Summary page 2.

## Indications for use
Enamelite Acryseal and Enamelite Acryseal-CB Spray Sealant is intended for use as a sealant/bonding agent intended to reline, repair, or rebase denture surfaces and CAD/CAM produced/milled acrylic and composite replacement dental restorations.

Source page: https://510kreport.com/device/K093019
Methodology: https://510kreport.com/methodology