510(k) · Cleared
ClearedFigaro Crowns Anterior Crown Kit, Figaro Crowns Posterior Crown Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Figaro Crowns, Inc. · EBF Material, Tooth Shade, Resin
Cleared on Jul 3, 2018 as substantially equivalent to K143694 (Rhondium, Ltd., 2015) after a 280-day review. Its family tree reaches back 3 generations to 1991.
- Decided
- Jul 3, 2018
- Review
- 280 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K910860 (1991). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK910860 All-Bond 2Bisco, Inc. · 1991
- 2 generations backK052501 Multiple Resin Tooth Bonding AgentCosmedent, Inc. · 2005 · Recalled
- 1 generation backK143694 Rhondium One-Visit-Crown (OVC)Rhondium, Ltd. · 2015 · Recalled
- This deviceK172952 Figaro Crowns Anterior Crown Kit, Figaro Crowns Posterior Crown KitFigaro Crowns, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K910860 | All-Bond 2 | Bisco, Inc. | 1991 | — |
| −2 | K052501 | Multiple Resin Tooth Bonding Agent | Cosmedent, Inc. | 2005 | 1 |
| −1 | K143694 | Rhondium One-Visit-Crown (OVC) | Rhondium, Ltd. | 2015 | 1 |
| 0 (this device) | K172952 | Figaro Crowns Anterior Crown Kit, Figaro Crowns Posterior Crown Kit | Figaro Crowns, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 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 |
|---|---|---|---|
| * | K143694 | Rhondium One-Visit-Crown (OVC)Summary page 4…olymer based Classification Name: Tooth Shade Resin Material Classification Regulations: 21 CFR 872.3690 Product Code EBF Classification: Class II Predicate Device: K143694 Rhondium One-Visit-Crown (OVC) Device Description: The Figaro Crown is a permanent preformed resin crown used on adult patients… | 2015 |
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 27 years and passes through 4 companies; a new generation was cleared every 9.6 years on median.
- 2 of the 6 ancestors have a recall of any class.
- 1 other device also cites its predicate K143694.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Figaro Preformed Dental Crown is intended for restoration of permanent teeth with a single unit crown.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172952 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172952: Figaro Crowns Anterior Crown Kit, Figaro Crowns Posterior Crown Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172952
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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