510(k) · Cleared

Cleared

Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner)

K200555510(k) TraditionalCleared May 13, 2021436-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

Prevest Denpro Limited · EMA Cement, Dental

Cleared on May 13, 2021 as substantially equivalent to K101869 (Silmet, Ltd., 2010) after a 436-day review. Its family tree reaches back 2 generations to 1995.

Decided: May 13, 2021
Review: 436 days
Class: Class II
Product code: EMA
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K946100 (1995). 7 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK946100 Fuji DuetGC America, Inc. · 1995
1 generation backK101869 Proglass Cements (One, Two Two LC, Nine, Plus, Silver)Silmet, Ltd. · 2010
This deviceK200555 Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior…Prevest Denpro Limited · 2021

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K946100	Fuji Duet	GC America, Inc.	1995	—
−1	K101869	Proglass Cements (One, Two Two LC, Nine, Plus, Silver)	Silmet, Ltd.	2010	—
0 (this device)	K200555	Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron…	Prevest Denpro Limited	2021	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	2	0
1998	2	0
1999	1	0

FIG. 1 — Lineage of K200555, 1995–2021Source: 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 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
*	K101869	Proglass Cements (One, Two Two LC, Nine, Plus, Silver) Summary page 5 …The dental cements contain ingredients found in the predicate and reference devices so no biocompatibility testing was done. Primary Predicate Device: ProGlass Cements K101869 from Silmet Reference Devices: Teethmate K131068 from Kuraray Ketac Conditioner K872984 from ESPE GMBH Riva Lutin…	Silmet, Ltd.	2010	—
†	K131068	Teethmate Desensitizer Set; Teethmate Desensitizer Powder; Teethmate Desensitizer Liquid	Kuraray Noritake Dental, Inc.	2013	—
†	K872984	Ketac-Conditioner	Espe GmbH (Us)	1988	—
†	K040393	Riva Luting	Southern Dental Industries, Inc.	2004	—
†	K031467	Glasionomer FX-II	Shofu Dental Corp.	2003	—

Also cleared against K101869: 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 26 years and passes through 3 companies; a new generation was cleared every 15.7 years on median.
None of the 7 ancestors has a recall.
2 other devices also cite its predicate K101869.

How does its category compare?

All EMA devices

EMA Cement, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?

Micron Bioactive Class III and V, Restoration of cervical erosions and root surface caries, Core buildup, Base/Liner Class I, limited Class I, temporary fillings Restoration of primary teeth Micron Superior Shades Al, A2, A3 Class 111, Class V, limited Class I Restoration of primary teeth, Core buildup Micron Superior Capsules Shades A1, A2, A3 Class III, Class V., limited Class | Restoration of primary teeth, Core buildup Micron Luting Cementation of…

Read the full statement (116 words)

Micron Bioactive

Class III and V, Restoration of cervical erosions and root surface caries,

Core buildup,

Base/Liner

Class I, limited Class I, temporary fillings

Restoration of primary teeth

Micron Superior Shades Al, A2, A3

Class 111, Class V, limited Class I

Restoration of primary teeth,

Core buildup

Micron Superior Capsules Shades A1, A2, A3

Class III, Class V., limited Class |

Restoration of primary teeth,

Core buildup

Micron Luting

Cementation of all types of metal, porcelain fused to metal, and resin crowns, inlays, onlays, and bridges

Cementation of orthodontic bands

Cementation of stainless steel crowns or orthodontic appliances retained with stainless steel crowns

Basc/Liner

Micron Dentin Conditioner

Dentin pre-treatment prior to filling with glass ionomer cement

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/K200555 · printed Nov 4, 2026

Cite this page

510(k) Report. “K200555: Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K200555

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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