510(k) · Cleared
ClearedTetric plus Fill;Tetric plus Flow
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ivoclar Vivadent, Inc. · EBF Material, Tooth Shade, Resin
Cleared on Jul 1, 2026 as substantially equivalent to K183380 (Ivoclar Vivadent, AG, 2019) after a 57-day review. Its family tree reaches back 2 generations to 2011.
- Decided
- Jul 1, 2026
- Review
- 57 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K111958 (2011). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K183380 | Tetric PowerFillSummary page 5…(Classification Code EBF) Common Name: Dental Composite Tetric plus Fill Predicate Device: Tetric PowerFill (K183380) by Ivoclar Vivadent AG, Liechtenstein Tetric plus Flow Predicate Device: Tetric PowerFill (K183380) by Ivoclar Vivade… | 2019 |
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?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 7.4 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K183380.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
Tetric plus Fill: — Missing tooth structure in anterior and posterior teeth Types of restorations: — Restorations of all types of permanent dentition (including the replacement of individual cusps in the posterior region) — Reconstructive build-ups — Restorations of deciduous teeth — Repair of composite / ceramic restorations — Direct veneers — Sealing of implant screw channels Tetric plus Flow: — Missing tooth structure in anterior and posterior teeth…
Read the full statement (143 words)
Tetric plus Fill:
— Missing tooth structure in anterior and posterior teeth
Types of restorations:
— Restorations of all types of permanent dentition (including the replacement of individual cusps in the posterior region)
— Reconstructive build-ups
— Restorations of deciduous teeth
— Repair of composite / ceramic restorations
— Direct veneers
— Sealing of implant screw channels
Tetric plus Flow:
— Missing tooth structure in anterior and posterior teeth
Types of restorations:
— Initial layer up to 4 mm in Class I and II restorations*
— Small direct restorations in permanent teeth (not occlusion-bearing)*
— Restorations of deciduous teeth
— Liner under direct restorations of all cavity classes
— Class V restorations
— Extended fissure sealings
— Repair of composite / ceramic restorations
— Sealing of implant screw channels
*In case of occlusion-bearing restorations, apply a final layer using a sculptable composite material.
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/K261485 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261485: Tetric plus Fill;Tetric plus Flow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261485
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026