510(k) · Cleared
ClearedVitro Fil LC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dfl Industria E Comercio SA · EMA Cement, Dental
Cleared on Feb 21, 2013 as substantially equivalent to K925032 (3M Company, 1992) and 2 other predicates after a 71-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Feb 21, 2013
- Review
- 71 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K946100 (1995). 9 ancestors in all, the oldest K913884 (1991). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K946100 | Fuji Duet | GC America, Inc. | 1995 | — |
| −1 | K101869 | Proglass Cements (One, Two Two LC, Nine, Plus, Silver) | Silmet, Ltd. | 2010 | — |
| 0 (this device) | K123824 | Vitro Fil LC | Dfl Industria E Comercio SA | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 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 EMA? 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 EMA device
- #1 K254109 G-Cem Universalscore 15.0 · 13 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K925032 | 3M Vitremer Tri-Cure Glass Ionomer SystemSummary page 1…roduct Codes EMA-21 CFR §872.3275 Proposed Regulatory Class Class II Predicate Device Identification Vitremer (K(925032), ProGlass Two LC (K(101869) and Fuji II LC (K913884) Description of Proposed D… | 1992 |
| * | K101869 | Proglass Cements (One, Two Two LC, Nine, Plus, Silver)Summary page 1…Class II Predicate Device Identification Vitremer (K(925032), ProGlass Two LC (K(101869) and Fuji II LC (K913884) Description of Proposed Device Virto Fil LC is a dental cement that is composed of varolus materials… | 2010 |
| * | K913884 | Fuji II LCSummary page 1…ass II Predicate Device Identification Vitremer (K(925032), ProGlass Two LC (K(101869) and Fuji II LC (K913884) Description of Proposed Device Virto Fil LC is a dental cement that is composed of varolus materials other than zinc oxide-eug… | 1991 |
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 18 years and passes through 3 companies; a new generation was cleared every 15.7 years on median.
- None of the 9 ancestors has a recall.
- 1 other device also cites its predicate K925032.
How does its category compare?
All EMA devicesEMA Cement, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · EMA
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EMA
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EMA
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EMA
9in 2025
MAUDE reports naming product code EMA, 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 | 6 | 48 | 0 | 33 |
| 2008 | 13 | 71 | 2 | 50 |
| 2009 | 10 | 86 | 1 | 90 |
| 2010 | 14 | 86 | 1 | 106 |
| 2011 | 8 | 79 | 5 | 224 |
| 2012 | 10 | 128 | 0 | 249 |
| 2013 | 12 | 178 | 0 | 385 |
| 2014 | 4 | 174 | 0 | 207 |
| 2015 | 9 | 134 | 0 | 85 |
| 2016 | 10 | 182 | 0 | 16 |
| 2017 | 3 | 141 | 0 | 13 |
| 2018 | 3 | 237 | 0 | 4 |
| 2019 | 7 | 127 | 0 | 12 |
| 2020 | 8 | 164 | 0 | 5 |
| 2021 | 4 | 184 | 0 | 8 |
| 2022 | 7 | 245 | 0 | 3 |
| 2023 | 2 | — | 1 | 6 |
| 2024 | 3 | 59 | 0 | 5 |
| 2025 | 10 | 106 | 0 | 9 |
| 2026 | 7 | 150 | 0 | — |
What is it indicated for?
As a structural reinforcement for fabricating and/or repairing Class III and Class V restorations
Restoration of root surface caries
Restorations of cervical erosions
Small Class I restorations
Primary teeth restoration
Core build up
Liner
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123824 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123824: Vitro Fil LC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123824
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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