# K183380: Tetric PowerFill

- Pathway: 510(k) (Abbreviated)
- Applicant: Ivoclar Vivadent, AG
- Decided: Mar 14, 2019 after 98 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 K111958 (2011). 1 ancestor in all.
2 later devices descend from it; 2 cite 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)
- K111958: Tetric Evoceram Bulk Fill, Ivoclar Vivadent, Inc. (2011) Summary page 4.

## Most influential descendants
- K261485: Tetric plus Fill;Tetric plus Flow (2026), 0 descendants of its own
- K254245: Zafira® (2026), 0 descendants of its own

## Indications for use
Conventional application (Light intensity ≤2,000 mW/cm2): - Restorations in the posterior region (Class I and II, including the replacement of individual cusps) - Class V restorations (cervical caries, root erosion, wedge-shaped defects) - Reconstructive build-ups - Restoration of deciduous teeth Light-curing using the 3sCure mode of Bluephase® PowerCure (Light Intensity 3,050 mW/cm2): - Restorations in the posterior region of permanent dentition (Class I and II, including the replacement of individual cusps) when light-cured from the occlusal aspect

Source page: https://510kreport.com/device/K183380
Methodology: https://510kreport.com/methodology