# K190758: Opus Bulk Fill APS, Opus Bulk Fill Flow APS

- Pathway: 510(k) (Traditional)
- Applicant: Dentscare Ltda
- Decided: Sep 4, 2019 after 163 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.
No later device cites it as a predicate yet.
0 of 2 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 5.

## Indications for use
Opus Bulk Fill APS - Direct restorations in posterior teeth (permanent and deciduous) in increments of up to Smm, including the occlusal surface; - Class V restorations (cervical caries, root erosion, wedge-shaped defects) - Reconstructive build-up;- - Base and lining of direct restorations; - Repair of small defects of the enamel; - Repair of temporary acrylic and resin materials Opus Bulk Fill Flow APS - Base/lining underneath direct restorations. - Small, non occlusal stress-bearing class I restorations according to minimally invasive filling therapy - Pit and fissure sealant - Tunnel-type preparation. - Repair of enamel defects - Bonding of tooth fragments. - Repair in composite resin - Non-carious cervical lesions. - Planning of preparation walls. - Core build-up

Source page: https://510kreport.com/device/K190758
Methodology: https://510kreport.com/methodology