# K082671: Herculite Ultra

- Pathway: 510(k) (Traditional)
- Applicant: Sybron Dental Specialties
- Decided: Dec 11, 2008 after 87 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 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) HerculiteXR V: named in the summary without a submission number

## Most influential descendants
- K162257: P1145 Dental Restorative (2016), 1 descendant of its own
- K223632: Premier's MultiMatch Universal Chameleon Restorative Composite (2022), 0 descendants of its own

## Recalls of this device
- Feb 23, 2009 · Not classified · Z-0916-2010: Sybron Dental Specialties is initiating a field correction on the Herculite Ultra, a dental composite restorative material, due to a mistake in the directions for use located in the Herculite techniqu

## Indications for use
Herculite Ultra is a dental composite restorative material intended to be used in all classes of cavities.

Source page: https://510kreport.com/device/K082671
Methodology: https://510kreport.com/methodology