510(k) · Cleared

Cleared

Estenia

K982164510(k) TraditionalCleared Aug 10, 199852-day reviewClass II21 CFR 872.3690

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

Kuraray America, Inc. · EBF Material, Tooth Shade, Resin

Cleared on Aug 10, 1998 as substantially equivalent to K962878 (Ivoclar North America, Inc., 1996) and 6 other predicates after a 52-day review. Its family tree reaches back 1 generation to 1993. 18 later devices descend from it.

Decided: Aug 10, 1998
Review: 52 days
Class: Class II
Product code: EBF
Recalls: None
Predicates: 7

Its longest line of descent runs back 1 generation to K932154 (1993). 7 ancestors in all. 18 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK932154 Conquest CrystalJeneric/Pentron, Inc. · 1993
This deviceK982164 EsteniaKuraray America, Inc. · 1998
Descendant · cites it directly · 17 of its ownK012707 EsteniaKuraray Medical, Inc. · 2001
Descendant · 2 generations on · 12 of its ownK042929 Estenia C&BKuraray Medical Kurashiki Plant · 2004
Descendant · 3 generations on · 6 of its ownK111982 Clearfil DC Core PlusKuraray America, Inc. · 2011
Descendant · 4 generations on · 4 of its ownK142625 PANAVIA SA Cement Plus Automix; (Universal (A2), White…Kuraray Noritake Dental, Inc. · 2015
Descendant · 3 generations on · 4 of its ownK063595 Clearfil Majesty PosteriorKuraray America, Inc. · 2007

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2001high 3 (2007) · low 0 (2002)2026

Most influential descendants

Showing 5 of 18 · See all

K012707EsteniaKuraray Medical, Inc. · 2001 · cites it directly17descendants
K042929Estenia C&BKuraray Medical Kurashiki Plant · 2004 · 2 generations on12descendants
K111982Clearfil DC Core PlusKuraray America, Inc. · 2011 · 3 generations on6descendants
K142625PANAVIA SA Cement Plus Automix; (Universal (A2), White, Translucent); Value Pack…Kuraray Noritake Dental, Inc. · 2015 · 4 generations on4descendants
K063595Clearfil Majesty PosteriorKuraray America, Inc. · 2007 · 3 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K932154	Conquest Crystal	Jeneric/Pentron, Inc.	1993	—
0 (this device)	K982164	Estenia	Kuraray America, Inc.	1998	—
+1	K012707	Estenia	Kuraray Medical, Inc.	2001	—
+2	K042929	Estenia C&B	Kuraray Medical Kurashiki Plant	2004	—
+3	K111982	Clearfil DC Core Plus	Kuraray America, Inc.	2011	—
+4	K142625	PANAVIA SA Cement Plus Automix; (Universal (A2), White, Translucent); Value…	Kuraray Noritake Dental, Inc.	2015	—
+3	K063595	Clearfil Majesty Posterior	Kuraray America, Inc.	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0
1995	1	0
1996	3	0
1997	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2003	1	0
2004	1	0
2007	3	0
2009	1	0
2010	1	0
2011	1	0
2013	1	0
2015	3	0
2017	1	0
2019	3	0
2021	1	0

FIG. 1 — Lineage of K982164, 1993–2021Source: 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

Get a 510(k) Report

What was it cleared against? (7)

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
*	K962878	Targis System Summary page 1 …ade resin material (21CFR 872.3690) 3) Common/Usual Name Resin-based crown and bridge material 4. Predicate devices: 1) TARGIS SYSTEM by IVOCLAR NORTH AMERICA, INC. (K962878) 2) BELLEGLASS HP DENTAL LABORATORY CROWN AND (K955331) BRIDGRE FABLICATION SYSTEM by KERR CORP. 3) ARTGLASS & KEVLOC by HERAEU…	Ivoclar North America, Inc.	1996	—
*	K955331	Belleglashp Summary page 1 …e Resin-based crown and bridge material 4. Predicate devices: 1) TARGIS SYSTEM by IVOCLAR NORTH AMERICA, INC. (K962878) 2) BELLEGLASS HP DENTAL LABORATORY CROWN AND (K955331) BRIDGRE FABLICATION SYSTEM by KERR CORP. 3) ARTGLASS & KEVLOC by HERAEUS KULZER, INC. (K954115) 4) SOLIDEX by SHOFU DENTAL COR…	Sybron Dental Specialties, Inc.	1996	—
*	K954115	Artglass & Kevloc Summary page 1 …H AMERICA, INC. (K962878) 2) BELLEGLASS HP DENTAL LABORATORY CROWN AND (K955331) BRIDGRE FABLICATION SYSTEM by KERR CORP. 3) ARTGLASS & KEVLOC by HERAEUS KULZER, INC. (K954115) 4) SOLIDEX by SHOFU DENTAL CORP. (K972292) 5) FIBREKOR by JENERIC/PENTRON, INC. (K964578) 6) DENTACOLOR VITA(VS) SHADE SYSTEM…	Heraeus Kulzer, Inc.	1995	—
*	K972292	Solidex Summary page 1 …DENTAL LABORATORY CROWN AND (K955331) BRIDGRE FABLICATION SYSTEM by KERR CORP. 3) ARTGLASS & KEVLOC by HERAEUS KULZER, INC. (K954115) 4) SOLIDEX by SHOFU DENTAL CORP. (K972292) 5) FIBREKOR by JENERIC/PENTRON, INC. (K964578) 6) DENTACOLOR VITA(VS) SHADE SYSTEM by HERAEUS (K940800) KULZER, INC. 7) CONQU…	Shofu Dental Corp.	1997	—
*	K964578	Fibrekor Summary page 1 …BLICATION SYSTEM by KERR CORP. 3) ARTGLASS & KEVLOC by HERAEUS KULZER, INC. (K954115) 4) SOLIDEX by SHOFU DENTAL CORP. (K972292) 5) FIBREKOR by JENERIC/PENTRON, INC. (K964578) 6) DENTACOLOR VITA(VS) SHADE SYSTEM by HERAEUS (K940800) KULZER, INC. 7) CONQUEST CRYSTAL by JENERIC/PENTRON, INC. (K932154)…	Jeneric/Pentron, Inc.	1996	—
*	K940800	Dentacolor Vita (VS) Shade System Summary page 1 …RAEUS KULZER, INC. (K954115) 4) SOLIDEX by SHOFU DENTAL CORP. (K972292) 5) FIBREKOR by JENERIC/PENTRON, INC. (K964578) 6) DENTACOLOR VITA(VS) SHADE SYSTEM by HERAEUS (K940800) KULZER, INC. 7) CONQUEST CRYSTAL by JENERIC/PENTRON, INC. (K932154) 5. Description for the premarket notification ESTENIA is c…	Heraeus Kulzer, Inc.	1994	—
*	K932154	Conquest Crystal Summary page 1 …92) 5) FIBREKOR by JENERIC/PENTRON, INC. (K964578) 6) DENTACOLOR VITA(VS) SHADE SYSTEM by HERAEUS (K940800) KULZER, INC. 7) CONQUEST CRYSTAL by JENERIC/PENTRON, INC. (K932154) 5. Description for the premarket notification ESTENIA is classified into tooth shade resin material, CFR 21 Section 872.3690, b…	Jeneric/Pentron, Inc.	1993	—

Also cleared against K962878: 3 other devices →

What descends from it? (18)

See all 18

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K012707	Estenia	Kuraray Medical, Inc.	2001	17

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?

None of the 7 ancestors has a recall.
Of its descendants, K012707 (Kuraray Medical, Inc., 2001) has gone furthest, with 17 descendants of its own.
3 other devices also cite its predicate K962878.

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.

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?

1) Jacket crown

2) Facing crown

3) Inlay and onlay

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/K982164 · printed Nov 4, 2026

Cite this page

510(k) Report. “K982164: Estenia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982164

Report an extraction error

Are you the manufacturer?

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