510(k) · Cleared
ClearedOpus Bulk Fill APS, Opus Bulk Fill Flow APS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentscare Ltda · EBF Material, Tooth Shade, Resin
Cleared on Sep 4, 2019 as substantially equivalent to K111958 (Ivoclar Vivadent, Inc., 2011) after a 163-day review. Its family tree reaches back 1 generation to 2011.
- Decided
- Sep 4, 2019
- Review
- 163 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K111958 (2011). No later device cites it as a predicate yet.
- Root · 1 generation backK111958 Tetric Evoceram Bulk FillIvoclar Vivadent, Inc. · 2011
- This deviceK190758 Opus Bulk Fill APS, Opus Bulk Fill Flow APSDentscare Ltda · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K111958 | Tetric Evoceram Bulk Fill | Ivoclar Vivadent, Inc. | 2011 | — |
| 0 (this device) | K190758 | Opus Bulk Fill APS, Opus Bulk Fill Flow APS | Dentscare Ltda | 2019 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EBF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new EBF device
- #1 K202846 Tera Harzscore 18.5 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate K111958.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · EBF
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBF
43in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBF
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBF
1in 2025
MAUDE reports naming product code EBF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 19 | 49 | 1 | 6 |
| 2008 | 14 | 79 | 42 | 10 |
| 2009 | 20 | 84 | 1 | 8 |
| 2010 | 19 | 75 | 6 | 31 |
| 2011 | 19 | 81 | 7 | 31 |
| 2012 | 11 | 86 | 0 | 62 |
| 2013 | 13 | 153 | 0 | 246 |
| 2014 | 10 | 112 | 0 | 195 |
| 2015 | 17 | 123 | 0 | 119 |
| 2016 | 20 | 205 | 0 | 143 |
| 2017 | 15 | 108 | 4 | 42 |
| 2018 | 15 | 115 | 0 | 8 |
| 2019 | 17 | 159 | 2 | 11 |
| 2020 | 15 | 190 | 1 | 2 |
| 2021 | 13 | 178 | 0 | 2 |
| 2022 | 17 | 63 | 0 | 2 |
| 2023 | 9 | 87 | 0 | 8 |
| 2024 | 18 | 120 | 0 | 5 |
| 2025 | 15 | 43 | 0 | 1 |
| 2026 | 16 | 59 | 2 | — |
What is it indicated for?
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. -…
Read the full statement (118 words)
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
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K190758 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190758: Opus Bulk Fill APS, Opus Bulk Fill Flow APS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190758
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026