510(k) · Cleared

Cleared

n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks,

K160262510(k) TraditionalCleared Sep 16, 2016227-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

Institut Straumann AG · EIH Powder, Porcelain

Cleared on Sep 16, 2016 as substantially equivalent to K051705 (Ivoclar Vivadent, Inc., 2005) after a 227-day review. Its family tree reaches back 1 generation to 2005. 4 later devices descend from it.

Decided: Sep 16, 2016
Review: 227 days
Class: Class II
Product code: EIH
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K051705 (2005). 4 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK051705 Ips E.Max Cad/Ips E.Max ZircadIvoclar Vivadent, Inc. · 2005 · Recalled
This deviceK160262 n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks,Institut Straumann AG · 2016
Descendant · cites it directly · 1 of its ownK202952 Amber Mill Q Series & Amber Mill Direct SeriesHass Corp. · 2021
Descendant · 2 generations on · 0 of its ownK233016 Dental Glass CeramicsShenzhen Yurucheng Dental Materials Co., Ltd. · 2023
Descendant · cites it directly · 0 of its ownK173410 n!ce for PlanmillInstitut Straumann AG · 2017
Descendant · cites it directly · 0 of its ownK170420 n!ce Glass Ceramic Blocks for Amann GirrbachInstitut Straumann AG · 2017

Most influential descendants

Showing 4 of 4 · See all

K202952Amber Mill Q Series & Amber Mill Direct SeriesHass Corp. · 2021 · cites it directly1descendant
K233016Dental Glass CeramicsShenzhen Yurucheng Dental Materials Co., Ltd. · 2023 · 2 generations on0descendants
K173410n!ce for PlanmillInstitut Straumann AG · 2017 · cites it directly0descendants
K170420n!ce Glass Ceramic Blocks for Amann GirrbachInstitut Straumann AG · 2017 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K051705	Ips E.Max Cad/Ips E.Max Zircad	Ivoclar Vivadent, Inc.	2005	10
0 (this device)	K160262	n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks,	Institut Straumann AG	2016	—
+1	K202952	Amber Mill Q Series & Amber Mill Direct Series	Hass Corp.	2021	—
+2	K233016	Dental Glass Ceramics	Shenzhen Yurucheng Dental Materials Co., Ltd.	2023	—
+1	K173410	n!ce for Planmill	Institut Straumann AG	2017	—
+1	K170420	n!ce Glass Ceramic Blocks for Amann Girrbach	Institut Straumann AG	2017	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2017	2	0
2021	1	0
2023	1	0

FIG. 1 — Lineage of K160262, 2005–2023Source: 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? (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	Applicant	Decided	Recalls
*	K051705	Ips E.Max Cad/Ips E.Max Zircad Summary page 4 …fication Name: Porcelain powder for clinical use (21 CFR 872.6660) Proprietary Name: Straumann® n!ce™ Glass-Ceramic Blocks Predicate Device:: K051705, IPS e.max CAD (Ivoclar Vivadent, Inc.) Reference Device(s): None Device Description: Straumann® n!ce™ glass…	Ivoclar Vivadent, Inc.	2005	10

Also cleared against K051705: 20 other devices →

What descends from it? (4)

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

Number	Device	Applicant	Decided	Descendants
K202952	Amber Mill Q Series & Amber Mill Direct Series	Hass Corp.	2021	1
K173410	n!ce for Planmill	Institut Straumann AG	2017	0
K170420	n!ce Glass Ceramic Blocks for Amann Girrbach	Institut Straumann AG	2017	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?

Its one ancestor has a recall.
Of its descendants, K202952 (Hass Corp., 2021) has gone furthest, with 1 descendant of its own.
20 other devices also cite its predicate K051705.

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?

Once finalized into a suitable design, the n!ce™ glass-ceramic blocks are indicated for use as inlays, onlays, veneers, partial crowns and crowns.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K160262 · printed Nov 6, 2026

Cite this page

510(k) Report. “K160262: n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160262

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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