510(k) · Cleared

Cleared

Agc Cem

K030168510(k) TraditionalCleared Mar 21, 200363-day reviewClass II21 CFR 872.3275

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

Wieland Dental + Technik GmbH & Co. KG · EMA Cement, Dental

Cleared on Mar 21, 2003 as substantially equivalent to K012316 (Dmg USA, Inc., 2001) after a 63-day review. Its family tree reaches back 2 generations to 1992.

Decided: Mar 21, 2003
Review: 63 days
Class: Class II
Product code: EMA
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K924151 (1992). 9 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK924151 Bisco D/C ResinomerBisco, Inc. · 1992
1 generation backK012316 Permacem / Permacem DualDmg USA, Inc. · 2001
This deviceK030168 Agc CemWieland Dental + Technik GmbH & Co. KG · 2003

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K924151	Bisco D/C Resinomer	Bisco, Inc.	1992	—
−1	K012316	Permacem / Permacem Dual	Dmg USA, Inc.	2001	—
0 (this device)	K030168	Agc Cem	Wieland Dental + Technik GmbH & Co. KG	2003	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0
1994	4	0
1995	1	0
1996	1	0

FIG. 1 — Lineage of K030168, 1992–2003Source: 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 EMA? 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 EMA device

#1 K254109 G-Cem Universalscore 15.0 · 13 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? (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
*	K012316	Permacem / Permacem Dual	Dmg USA, Inc.	2001	—

Also cleared against K012316: 2 other devices →

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 11 years and passes through 3 companies; a new generation was cleared every 8.7 years on median.
None of the 9 ancestors has a recall.
2 other devices also cite its predicate K012316.

How does its category compare?

All EMA devices

EMA Cement, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EMA

10in 2025

2007high 14 (2010) · low 2 (2023)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EMA

106in 2025

2007high 245 (2022) · low 48 (2007)2026

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

Recalls per year · EMA

1in 2023

2007high 5 (2011) · low 0 (2007)2026

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

Adverse event reports per year · EMA

9in 2025

2007high 385 (2013) · low 3 (2022)2025

MAUDE reports naming product code EMA, 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	6	48	0	33
2008	13	71	2	50
2009	10	86	1	90
2010	14	86	1	106
2011	8	79	5	224
2012	10	128	0	249
2013	12	178	0	385
2014	4	174	0	207
2015	9	134	0	85
2016	10	182	0	16
2017	3	141	0	13
2018	3	237	0	4
2019	7	127	0	12
2020	8	164	0	5
2021	4	184	0	8
2022	7	245	0	3
2023	2	—	1	6
2024	3	59	0	5
2025	10	106	0	9
2026	7	150	0	—

What is it indicated for?

AGC@Cem is a dental self-curing compomer cement for the permanent cementation of AGC@Supracaps in tertiary structures such as secondary telescopic crowns in chrome cobalt substructures, or Supracaps in implant supraconstructions.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K030168 · printed Nov 4, 2026

Cite this page

510(k) Report. “K030168: Agc Cem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K030168

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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