510(k) · Cleared

Cleared

TheraCem

K161256510(k) TraditionalCleared Jul 29, 201686-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

Cleared on Jul 29, 2016 as substantially equivalent to K082449 (Bisco, Inc., 2008) after an 86-day review. Its family tree reaches back 1 generation to 2008. 1 later device descends from it.

Decided: Jul 29, 2016
Review: 86 days
Class: Class II
Product code: EMA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K082449 (2008). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK082449 Biscem Translucent, Model D-45011; Biscem Opaque, Model D-45012Bisco, Inc. · 2008
This deviceK161256 TheraCemBisco, Inc. · 2016
Descendant · cites it directly · 0 of its ownK192007 TheraBase, TheraBase CaBisco, Inc. · 2020

Most influential descendants

Showing 1 of 1 · See all

K192007TheraBase, TheraBase CaBisco, Inc. · 2020 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K082449	Biscem Translucent, Model D-45011; Biscem Opaque, Model D-45012	Bisco, Inc.	2008	—
0 (this device)	K161256	TheraCem	Bisco, Inc.	2016	—
+1	K192007	TheraBase, TheraBase Ca	Bisco, Inc.	2020	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2020	1	0

FIG. 1 — Lineage of K161256, 2008–2020Source: 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
*	K082449	Biscem Translucent, Model D-45011; Biscem Opaque, Model D-45012 Summary page 4 …21 CFR 872.3275 Predicate Devices: TheraCem is substantially equivalent to: Primary Predicate: BisCem by Bisco, Inc. K082449 Reference Predicate: NuSmile Biocem by NuSmile, LTD / Pulpdent K123265 Indications for Use…	Bisco, Inc.	2008	—
†	K123265	Rmgi Low Viscosity	Pulpdent Corporation	2012	—

Also cleared against K082449: 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
K192007	TheraBase, TheraBase Ca	Bisco, Inc.	2020	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 no recall.
Of its descendants, K192007 (Bisco, Inc., 2020) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K082449.

How does its category compare?

All EMA devices

EMA Cement, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

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?

Use TheraCem to cement the following:

1. Metal crowns, bridges, inlays and onlays (includes porcelain-fused-to-metal and composite-to-metal)

2. Porcelain, Ceramic Crowns, inlays and onlays (includes alumina and zirconia)

3. Resin crowns, bridges, inlays and onlays (resin-based composite/composite-ceramic hybrid)

4. Metal (prefabricated or cast) and non-metal/fiber endodontic posts

5. Implant supported restorations

6. Orthodontic Appliances (brackets, bands)

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K161256 · printed Nov 4, 2026

Cite this page

510(k) Report. “K161256: TheraCem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K161256

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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