510(k) · Cleared
ClearedProfil Composites (Profil, Profil Flow)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Silmet, Ltd. · EBF Material, Tooth Shade, Resin
Cleared on Feb 2, 2011 as substantially equivalent to K051867 (Voco GmbH, 2005) and 2 other predicates after a 97-day review. Its family tree reaches back 1 generation to 2002. 1 later device descends from it.
- Decided
- Feb 2, 2011
- Review
- 97 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K020342 (2002). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K220077IMICRYL Composite, Composite Flow MaterialsImicryl Dis Malzemeleri Sanayi VE Ticaret AS · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K020342 | Unifil Flow | GC America, Inc. | 2002 | — |
| 0 (this device) | K103190 | Profil Composites (Profil, Profil Flow) | Silmet, Ltd. | 2011 | — |
| +1 | K220077 | IMICRYL Composite, Composite Flow Materials | Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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? (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 |
|---|---|---|---|
| * | K051867 | GrandioSummary page 4…age 4 === SILMET R Substantial Equivalence The information provided in this 510(k) submission shows that the ProFil Composites are substantially equivalent to: GrandiO (K051867, VOCO America) Unifil Flow (K020342, GC America) Filtek Supreme Ultra Flowable (K100235, 3M ESPE Dental Products) The equivalenc… | 2005 |
| * | K020342 | Unifil FlowSummary page 1…ling Materials Regulatory class: Class 11 Predicate Devices GrandiO (KOS51867, VOCO America) Unifil Flow (K020342, GC America) Filtek Supreme Ultra Flowable (K100235, 3M ESPE Dental Products) Description The ProFil Composites are li… | 2002 |
| * | K100235 | Filtek Supreme Ultra Flowable RestorativeSummary page 1…s GrandiO (KOS51867, VOCO America) Unifil Flow (K020342, GC America) Filtek Supreme Ultra Flowable (K100235, 3M ESPE Dental Products) Description The ProFil Composites are light cured restorative micro hybrid composite resins for use in… | 2010 |
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 |
|---|---|---|---|
| K220077 | IMICRYL Composite, Composite Flow Materials | 2022 | 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?
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
ProFil Direct anterior & posterior restorations
Core Build ups
Splinting
ProFil Flow Class 111, V & smaller Class IV restorations
Base/liner in Class I & Class 11 restorations
Repair resin, porcelain & acrylic temporary materials
Pit & fissure sealant
Undercut blockout
Restoration of minimally invasive cavity preparations
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103190 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103190: Profil Composites (Profil, Profil Flow).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103190
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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