# K092539: Seamfree

- Pathway: 510(k) (Traditional)
- Applicant: Apex Dental Materials, Inc.
- Decided: Oct 1, 2009 after 43 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
Longest line of descent: 1 generation back to K030585 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030585: Sculpting Resin, Bisco, Inc. (2003) Summary page 1.

## Indications for use
Seamfree is intended to be used to lubricate restorative instruments and materials. It can be used in all dental restorations and with any methylmethacrylate based material.

Source page: https://510kreport.com/device/K092539
Methodology: https://510kreport.com/methodology