510(k) · Cleared
ClearedTetric PowerFill
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ivoclar Vivadent, AG · EBF Material, Tooth Shade, Resin
Cleared on Mar 14, 2019 as substantially equivalent to K111958 (Ivoclar Vivadent, Inc., 2011) after a 98-day review. Its family tree reaches back 1 generation to 2011. 2 later devices descend from it.
- Decided
- Mar 14, 2019
- Review
- 98 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K111958 (2011). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK111958 Tetric Evoceram Bulk FillIvoclar Vivadent, Inc. · 2011
- This deviceK183380 Tetric PowerFillIvoclar Vivadent, AG · 2019
- Descendant · cites it directly · 0 of its ownK261485 Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK254245 Zafira®New Stetic, SA · 2026
Most influential descendants
Showing 2 of 2 · See allView 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) | K183380 | Tetric PowerFill | Ivoclar Vivadent, AG | 2019 | — |
| +1 | K261485 | Tetric plus Fill;Tetric plus Flow | Ivoclar Vivadent, Inc. | 2026 | — |
| +1 | K254245 | Zafira® | New Stetic, SA | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 2 | 0 |
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 |
|---|---|---|---|
| * | K111958 | Tetric Evoceram Bulk FillSummary page 4…me: Material, Tooth Shade, Resin (872.3690) (Classification Code EBF) Predicate Device: Tetric EvoCeram Bulk Fill (K111958) by Ivoclar Vivadent, AG Device Description: Tetric® PowerFill is a light-curing radiopaque resin-based composite f… | 2011 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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?
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183380 · printed Nov 4, 2026
Cite this page
510(k) Report. “K183380: Tetric PowerFill.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K183380
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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