510(k) · Cleared

Cleared

L- OVC

K162677510(k) TraditionalCleared Dec 21, 201686-day reviewClass II21 CFR 872.6660

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

Cleared on Dec 21, 2016 as substantially equivalent to K143694 (Rhondium, Ltd., 2015) and 3 other predicates after an 86-day review. Its family tree reaches back 3 generations to 1991.

Decided: Dec 21, 2016
Review: 86 days
Class: Class II
Product code: EIH
Recalls: None
Predicates: 4

Its longest line of descent runs back 3 generations to K910611 (1991). 15 ancestors in all, the oldest K910860 (1991). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK910611 Nobelpharma Ceraone Abutment SystemNobelpharma USA, Inc. · 1991
2 generations backK032562 Proceara Copings and PonticNobel Biocare AB · 2004
1 generation backK100512 Nobelprocera Ips E.Max CrownNobel Biocare AB · 2010
This deviceK162677 L- OVCRhondium, Ltd. · 2016

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K910611	Nobelpharma Ceraone Abutment System	Nobelpharma USA, Inc.	1991	—
−2	K032562	Proceara Copings and Pontic	Nobel Biocare AB	2004	—
−1	K100512	Nobelprocera Ips E.Max Crown	Nobel Biocare AB	2010	—
0 (this device)	K162677	L- OVC	Rhondium, Ltd.	2016	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0
2000	1	0
2001	1	0
2003	1	0
2005	3	0
2008	1	0
2009	2	0
2013	1	0
2015	1	0

FIG. 1 — Lineage of K162677, 1991–2016Source: 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 EIH? 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 EIH device

#1 K192231 Dental Glass Ceramics Blocksscore 15.2 · 3 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
*	K143694	Rhondium One-Visit-Crown (OVC) Summary page 4 …EIH Classification Panel: Dental Products Panel Reviewing Branch: Dental Devices Branch PREDICATE DEVICE INFORMATION Primary Predicate K143694, Rhondium One-Visit-Crown (OVC), Rhondium, Ltd Reference Predicates K100512, NobelProcera IPS e.max Crown, Nobel Biocare AB K090…	Rhondium, Ltd.	2015	1
*	K100512	Nobelprocera Ips E.Max Crown Summary page 4 …ch: Dental Devices Branch PREDICATE DEVICE INFORMATION Primary Predicate K143694, Rhondium One-Visit-Crown (OVC), Rhondium, Ltd Reference Predicates K100512, NobelProcera IPS e.max Crown, Nobel Biocare AB K090826, Monobond Plus, Ivoclar Vivadent, Inc. K123397, Multilink Automix, Ivocla…	Nobel Biocare AB	2010	—
*	K090826	Monobond Plus Summary page 4 …DEVICE INFORMATION Primary Predicate K143694, Rhondium One-Visit-Crown (OVC), Rhondium, Ltd Reference Predicates K100512, NobelProcera IPS e.max Crown, Nobel Biocare AB K090826, Monobond Plus, Ivoclar Vivadent, Inc. K123397, Multilink Automix, Ivoclar Vivadent, AG . 510(k) Summary…	Ivoclar Vivadent, Inc.	2009	—
*	K123397	Multilink Automix Summary page 4 …hondium One-Visit-Crown (OVC), Rhondium, Ltd Reference Predicates K100512, NobelProcera IPS e.max Crown, Nobel Biocare AB K090826, Monobond Plus, Ivoclar Vivadent, Inc. K123397, Multilink Automix, Ivoclar Vivadent, AG . 510(k) Summary…	Ivoclar Vivadent, AG	2013	—

Also cleared against K143694: 1 other device →

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 25 years and passes through 3 companies; a new generation was cleared every 6.5 years on median.
3 of the 15 ancestors have a recall of any class.
1 other device also cites its predicate K143694.

How does its category compare?

All EIH devices

EIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · EIH

13in 2025

2007high 28 (2024) · low 9 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EIH

84in 2025

2007high 187 (2016) · low 63 (2007)2026

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

Recalls per year · EIH

1in 2025

2007high 21 (2016) · low 0 (2007)2026

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

Adverse event reports per year · EIH

1in 2025

2007high 22 (2021) · low 0 (2007)2025

MAUDE reports naming product code EIH, 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	15	63	0	0
2008	15	87	0	1
2009	15	79	0	0
2010	14	89	0	0
2011	14	80	0	1
2012	9	96	0	0
2013	16	107	0	6
2014	18	118	0	1
2015	23	118	0	0
2016	22	187	21	4
2017	16	149	0	1
2018	10	139	0	2
2019	16	125	0	1
2020	13	155	0	0
2021	17	131	0	22
2022	16	89	0	0
2023	15	114	0	0
2024	28	89	0	7
2025	13	84	1	1
2026	14	73	0	—

What is it indicated for?

L-OVC is intended for restoration of permanent teeth with a single unit crown.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K162677 · printed Nov 6, 2026

Cite this page

510(k) Report. “K162677: L- OVC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162677

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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