510(k) · Cleared
ClearedLlis, Vittra 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 Dec 16, 2019 as substantially equivalent to K183476 (3M Espe Dental Products, 2019) after a 216-day review. Its family tree reaches back 3 generations to 2008. 1 later device descends from it.
- Decided
- Dec 16, 2019
- Review
- 216 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K083610 (2008). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK083610 Filtek Supreme Ultra Universal Restorative3M Company · 2008
- 2 generations backK141081 Filtek Bulk Fill Posterior Restroative3M Espe Dental Products · 2014
- 1 generation backK183476 3M Filtek Universal Restorative3M Espe Dental Products · 2019
- This deviceK191306 Llis, Vittra APSDentscare Ltda · 2019
- Descendant · cites it directly · 0 of its ownK210231 Vittra APS UniqueDentscare Ltda · 2021
Most influential descendants
Showing 1 of 1 · See all- K210231Vittra APS UniqueDentscare Ltda · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K083610 | Filtek Supreme Ultra Universal Restorative | 3M Company | 2008 | — |
| −2 | K141081 | Filtek Bulk Fill Posterior Restroative | 3M Espe Dental Products | 2014 | — |
| −1 | K183476 | 3M Filtek Universal Restorative | 3M Espe Dental Products | 2019 | — |
| 0 (this device) | K191306 | Llis, Vittra APS | Dentscare Ltda | 2019 | — |
| +1 | K210231 | Vittra APS Unique | Dentscare Ltda | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 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 |
|---|---|---|---|
| * | K183476 | 3M Filtek Universal RestorativeSummary page 5…l Equivalence: The Llis, VITTRA APS is equivalent with the following products: 510(k) Number Model Company K183476 3M™ ESPE™ Filtek™ Z250 Universal 3M COMPANY Restorative… | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210231 | Vittra APS Unique | 2021 | 0 |
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 11 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K210231 (Dentscare Ltda, 2021) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K183476.
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?
The Llis and VITTRA APS composite is suitable for use in:
- Direct restorations in anterior and posterior teeth (I, II, III, IV, V e VI);
- Core build-ups;
- Teeth splinting;
- Indirect restorations such as inlays, onlays and veneers.
- Direct veneers with composites;
- Restoration of deciduous teeth
- Diastema closing or reduction;
- Modification of teeth's shape (e.g.: conoid teeth);
- Cementation of tooth fragments;
- Porcelain/composite repairs;
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191306 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191306: Llis, Vittra APS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191306
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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