# K111958: Tetric Evoceram Bulk Fill

- Pathway: 510(k) (Traditional)
- Applicant: Ivoclar Vivadent, Inc.
- Decided: Oct 14, 2011 after 95 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
No predicates in its family tree.
15 later devices descend from it; 4 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K141081: Filtek Bulk Fill Posterior Restroative (2014), 9 descendants of its own
- K183476: 3M Filtek Universal Restorative (2019), 5 descendants of its own
- K183380: Tetric PowerFill (2019), 2 descendants of its own
- K241147: Any-Com (2024), 1 descendant of its own
- K191306: Llis, Vittra APS (2019), 1 descendant of its own

## Indications for use
Restoration of Deciduous teeth Restorations in the posterior region (Classes I and ii) Class V restorations (cervical caries, root erosion, wedge-shaped defects) Extended fissure sealing in molars and premnolars

Source page: https://510kreport.com/device/K111958
Methodology: https://510kreport.com/methodology