510(k) · Cleared

Recalled · Class II · 2019

Rhondium One-Visit-Crown (OVC)

K143694510(k) TraditionalCleared May 15, 2015142-day reviewClass II21 CFR 872.3690Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Rhondium, Ltd. · EBF Material, Tooth Shade, Resin

Cleared on May 15, 2015 as substantially equivalent to K072733 (3M Company, 2008) and 3 other predicates after a 142-day review. Its family tree reaches back 2 generations to 1991. 2 later devices descend from it. It has been recalled once.

Decided: May 15, 2015
Review: 142 days
Class: Class II
Product code: EBF
Recalls: 1
Predicates: 4

Its longest line of descent runs back 2 generations to K910860 (1991). 5 ancestors in all. 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 2 generations backK910860 All-Bond 2Bisco, Inc. · 1991
1 generation backK052501 Multiple Resin Tooth Bonding AgentCosmedent, Inc. · 2005 · Recalled
This deviceK143694 Rhondium One-Visit-Crown (OVC)Rhondium, Ltd. · 2015
Descendant · cites it directly · 0 of its ownK172952 Figaro Crowns Anterior Crown Kit, Figaro Crowns Posterior Crown KitFigaro Crowns, Inc. · 2018
Descendant · cites it directly · 0 of its ownK162677 L- OVCRhondium, Ltd. · 2016

Most influential descendants

Showing 2 of 2 · See all

K172952Figaro Crowns Anterior Crown Kit, Figaro Crowns Posterior Crown KitFigaro Crowns, Inc. · 2018 · cites it directly0descendants
K162677L- OVCRhondium, Ltd. · 2016 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K910860	All-Bond 2	Bisco, Inc.	1991	—
−1	K052501	Multiple Resin Tooth Bonding Agent	Cosmedent, Inc.	2005	1
0 (this device)	K143694	Rhondium One-Visit-Crown (OVC)	Rhondium, Ltd.	2015	—
+1	K172952	Figaro Crowns Anterior Crown Kit, Figaro Crowns Posterior Crown Kit	Figaro Crowns, Inc.	2018	—
+1	K162677	L- OVC	Rhondium, Ltd.	2016	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2008	1	0
2009	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2016	1	0
2018	1	0

FIG. 1 — Lineage of K143694, 1991–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (4)

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	Applicant	Decided	Recalls
*	K072733	3M Espe Adult Crown Summary page 6 …gulation of medical devices, the subject device is substantially equivalent in indications and design principles to the following legally marketed predicate devices: K072733, 3M™ ESPE™ Adult Crown, 3M ESPE Dental Products; K050401, Ceramage, ShoFu Dental Corporation; K052501, Resin Tooth Bondin…	3M Company	2008	—
*	K050401	Ceramage Summary page 6 …lly equivalent in indications and design principles to the following legally marketed predicate devices: K072733, 3M™ ESPE™ Adult Crown, 3M ESPE Dental Products; K050401, Ceramage, ShoFu Dental Corporation; K052501, Resin Tooth Bonding Agent, Cosmedent, Incorporated; and K092319, Star VPS,…	Shofu Dental Corp.	2005	—
*	K052501	Multiple Resin Tooth Bonding Agent Summary page 6 …es to the following legally marketed predicate devices: K072733, 3M™ ESPE™ Adult Crown, 3M ESPE Dental Products; K050401, Ceramage, ShoFu Dental Corporation; K052501, Resin Tooth Bonding Agent, Cosmedent, Incorporated; and K092319, Star VPS, First Half, First Quarter, Danville Materials, In…	Cosmedent, Inc.	2005	1
*	K092319	Star VPS, Model 80014-01, First Quater, Model 90649, First Half, Model 89387 Summary page 6 …3M™ ESPE™ Adult Crown, 3M ESPE Dental Products; K050401, Ceramage, ShoFu Dental Corporation; K052501, Resin Tooth Bonding Agent, Cosmedent, Incorporated; and K092319, Star VPS, First Half, First Quarter, Danville Materials, Incorporated. The primary predicate device is K072733. A comparison of…	Danville Materials, Inc.	2009	—

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K172952	Figaro Crowns Anterior Crown Kit, Figaro Crowns Posterior Crown Kit	Figaro Crowns, Inc.	2018	0
K162677	L- OVC	Rhondium, Ltd.	2016	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jan 31, 2019	Class II	Z-0708-2020	Employee error	The product was mislabeled with an incorrect expiration date.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 14.5 years on median.
1 of the 5 ancestors has a recall of any class.
Of its descendants, K172952 (Figaro Crowns, Inc., 2018) has gone furthest, with 0 descendants of its own.

How does its category compare?

All EBF devices

EBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · EBF

15in 2025

2007high 20 (2009) · low 9 (2023)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EBF

43in 2025

2007high 205 (2016) · low 43 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · EBF

1in 2020

2007high 42 (2008) · low 0 (2012)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · EBF

1in 2025

2007high 246 (2013) · low 1 (2025)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?

Rhondium One-Visit-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/K143694 · printed Nov 6, 2026

Cite this page

510(k) Report. “K143694: Rhondium One-Visit-Crown (OVC).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143694

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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