510(k) · Cleared

Cleared

Bellus Shading Kit

K090718510(k) TraditionalCleared Sep 21, 2009187-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

3M Espe AG Dental Products · EIH Powder, Porcelain

Cleared on Sep 21, 2009 as substantially equivalent to K980986 (Ivoclar USA, Inc., 1998) and 3 other predicates after a 187-day review. Its family tree reaches back 3 generations to 1981. 1 later device descends from it.

Decided: Sep 21, 2009
Review: 187 days
Class: Class II
Product code: EIH
Recalls: None
Predicates: 4

Its longest line of descent runs back 3 generations to K812116 (1981). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 3 generations backK812116 PermagumEspe-Premier Sales Co. · 1981
2 generations backK960547 Dimension Penta/Dimension Garant L/Polyvinyl Siloxane AdhesiveEspe GmbH & Co. Kg. · 1996
1 generation backK974231 Position Penta, Position Penta QuickEspe GmbH & Co. Kg. · 1998
This deviceK090718 Bellus Shading Kit3M Espe AG Dental Products · 2009
Descendant · cites it directly · 0 of its ownK130604 Universal Paste Stains and GlazePrismatik Dentalcraft, Inc. · 2013

Most influential descendants

Showing 1 of 1 · See all

K130604Universal Paste Stains and GlazePrismatik Dentalcraft, Inc. · 2013 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K812116	Permagum	Espe-Premier Sales Co.	1981	—
−2	K960547	Dimension Penta/Dimension Garant L/Polyvinyl Siloxane Adhesive	Espe GmbH & Co. Kg.	1996	—
−1	K974231	Position Penta, Position Penta Quick	Espe GmbH & Co. Kg.	1998	—
0 (this device)	K090718	Bellus Shading Kit	3M Espe AG Dental Products	2009	—
+1	K130604	Universal Paste Stains and Glaze	Prismatik Dentalcraft, Inc.	2013	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1988	1	0
1998	1	0
2001	1	0
2002	1	0
2006	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0

FIG. 1 — Lineage of K090718, 1981–2013Source: 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

Get a 510(k) Report

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
*	K980986	Procad Summary page 1 ….......... Colors, stains, shades, glaze Predicate Device IPS Empress Universal Shade/Stains ......................... Presumably K980986 by Ivoclar Vivadent Glass Ceramics "Jolly" by 3M ESPE ........................ K053438…	Ivoclar USA, Inc.	1998	—
*	K053438	Glass Ceramics Summary page 1 …rsal Shade/Stains ......................... Presumably K980986 by Ivoclar Vivadent Glass Ceramics "Jolly" by 3M ESPE ........................ K053438 Lava Ceram by 3M ESPE .......................................... K011394 Position Penta by 3M ESPE ..…	3M Espe AG Dental Products	2006	—
*	K011394	Lava Frame, Lava Frame Shade, Lava Ceram Summary page 1 …Vivadent Glass Ceramics "Jolly" by 3M ESPE ........................ K053438 Lava Ceram by 3M ESPE .......................................... K011394 Position Penta by 3M ESPE ....................................... K974231 2nd Amendment K090718…	Espe Dental AG	2001	—
*	K974231	Position Penta, Position Penta Quick Summary page 1 …38 Lava Ceram by 3M ESPE .......................................... K011394 Position Penta by 3M ESPE ....................................... K974231 2nd Amendment K090718 3M ESPE AG…	Espe GmbH & Co. Kg.	1998	—

Also cleared against K980986: 3 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K130604	Universal Paste Stains and Glaze	Prismatik Dentalcraft, Inc.	2013	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?

The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 11.6 years on median.
None of the 8 ancestors has a recall.
Of its descendants, K130604 (Prismatik Dentalcraft, Inc., 2013) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K980986.

How does its category compare?

All EIH devices

EIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?

Color staining and glazing of glass ceramic restorations made from 3M ESPE's Glass Ceramics "Jolly".

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K090718 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090718: Bellus Shading Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090718

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