# K945604: Ecliptomer

- Pathway: 510(k) (Traditional)
- Applicant: Bisco, Inc.
- Decided: Jan 3, 1995 after 49 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
No predicates in its family tree.
5 later devices descend from it; 4 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K020570: Simplicity (2002), 2 descendants of its own
- K061981: Surpass (2006), 1 descendant of its own
- K120767: ES Bond (2012), 0 descendants of its own
- K093019: Enamelite Acryseal Spray Sealant (2009), 0 descendants of its own
- K992838: Adhere Conditioner, Adhere Primer, Adhere LC Adhesive, Adhere DC Adhere DC Activator, Adhere Cylanate (1999), 0 descendants of its own

Source page: https://510kreport.com/device/K945604
Methodology: https://510kreport.com/methodology