# K061981: Surpass

- Pathway: 510(k) (Abbreviated)
- Applicant: Apex Dental Materials, Inc.
- Decided: Jul 31, 2006 after 18 days
- Product code: KLE (Agent, Tooth Bonding, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K945604 (1995). 2 ancestors in all.
1 later device descends 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)
- K945604: Ecliptomer, Bisco, Inc. (1995) Summary page 1.
- K020570: Simplicity, Apex Dental Materials, Inc. (2002) Summary page 3.

## Most influential descendants
- K093019: Enamelite Acryseal Spray Sealant (2009), 0 descendants of its own

## Indications for use
* Restorations: to seal enamel/dentin prior to restoring with light-cured or self-cured composite materials. * Indirect Restorations: to seal a preparation when using a light-cured, self-cured or dual-cured composite cement or glass ionomer or resin-modified glass ionomer cement. * Desensitization: to treat hypersensitive and/or exposed root surfaces. * To bond in a post and core

Source page: https://510kreport.com/device/K061981
Methodology: https://510kreport.com/methodology