510(k) Report

510(k) · Cleared

Cleared

Proglass Cements (One, Two Two LC, Nine, Plus, Silver)

K101869510(k) TraditionalCleared Sep 29, 201089-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

Silmet, Ltd. · EMA Cement, Dental

Cleared on Sep 29, 2010 as substantially equivalent to K980695 (GC America, Inc., 1998) and 5 other predicates after an 89-day review. Its family tree reaches back 1 generation to 1995. 3 later devices descend from it.

Decided
Sep 29, 2010
Review
89 days
Class
Class II
Product code
EMA
Recalls
None
Predicates
6

Its longest line of descent runs back 1 generation to K946100 (1995). 6 ancestors in all. 3 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 1 other ancestor1998: 2 other ancestors1996: 2 other ancestors2021: 2 descendants cleared2013: 1 descendant clearedK946100 · Fuji Duet · GC America, Inc. · 19951995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors 1 generation forward: 3 descendants K946100 · Fuji Duet · GC America, Inc. · 19950
  1. Root · 1 generation backK946100 Fuji DuetGC America, Inc. · 1995
  2. This deviceK101869 Proglass Cements (One, Two Two LC, Nine, Plus, Silver)Silmet, Ltd. · 2010
  3. Descendant · cites it directly · 0 of its ownK210473 Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova…Imicryl Dis Malzemeleri Sanayi VE Ticaret AS · 2021
  4. Descendant · cites it directly · 0 of its ownK200555 Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior…Prevest Denpro Limited · 2021
  5. Descendant · cites it directly · 0 of its ownK123824 Vitro Fil LCDfl Industria E Comercio SA · 2013

Most influential descendants

Showing 3 of 3 · See all
  • K210473Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass…Imicryl Dis Malzemeleri Sanayi VE Ticaret AS · 2021 · cites it directly0descendants
  • K200555Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior…Prevest Denpro Limited · 2021 · cites it directly0descendants
  • K123824Vitro Fil LCDfl Industria E Comercio SA · 2013 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K946100Fuji DuetGC America, Inc.1995—
0 (this device)K101869Proglass Cements (One, Two Two LC, Nine, Plus, Silver)Silmet, Ltd.2010—
+1K210473Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF…Imicryl Dis Malzemeleri Sanayi VE Ticaret AS2021—
+1K200555Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron…Prevest Denpro Limited2021—
+1K123824Vitro Fil LCDfl Industria E Comercio SA2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199620
199820
199910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
202120
FIG. 1 — Lineage of K101869, 1995–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K254109 G-Cem Universalscore 15.0 · 13 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (6)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K980695FUJI I
Summary page 1
…n Name: Glass lonomner Cements Regulatory class: Class II Predicate Devices Fuji I (K980695, GC America) Fuji II (K980682, GC America) Fuji II LC (K961584, GC America)…
GC America, Inc.1998—
*K980682Fuji II
Summary page 1
…Regulatory class: Class II Predicate Devices Fuji I (K980695, GC America) Fuji II (K980682, GC America) Fuji II LC (K961584, GC America) Fuji IX (K961448, GC America)…
GC America, Inc.1998—
*K961584Fuji II LC (Improved)
Summary page 1
…Predicate Devices Fuji I (K980695, GC America) Fuji II (K980682, GC America) Fuji II LC (K961584, GC America) Fuji IX (K961448, GC America) Fuji Duet (Fuji Plus) (K946100 GC America)…
GC America, Inc.1996—
*K961448Fuji IX GP
Summary page 1
…(K980695, GC America) Fuji II (K980682, GC America) Fuji II LC (K961584, GC America) Fuji IX (K961448, GC America) Fuji Duet (Fuji Plus) (K946100 GC America) Miracle Mix (K(984505, GC America)…
GC America, Inc.1996—
*K946100Fuji Duet
Summary page 1
…(K980682, GC America) Fuji II LC (K961584, GC America) Fuji IX (K961448, GC America) Fuji Duet (Fuji Plus) (K946100 GC America) Miracle Mix (K(984505, GC America) Description The ProGlass cements…
GC America, Inc.1995—
*K984505Miracle Mix Powder/Liquid
Summary page 1
…961584, GC America) Fuji IX (K961448, GC America) Fuji Duet (Fuji Plus) (K946100 GC America) Miracle Mix (K(984505, GC America) Description The ProGlass cements are classified as a Dental Cement (21 C.F.R. part 872.327…
GC America, Inc.1999—

Also cleared against K980695: 2 other devices →

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K210473Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass…Imicryl Dis Malzemeleri Sanayi VE Ticaret AS20210
K200555Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior…Prevest Denpro Limited20210
K123824Vitro Fil LCDfl Industria E Comercio SA20130

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?

  • None of the 6 ancestors has a recall.
  • Of its descendants, K210473 (Imicryl Dis Malzemeleri Sanayi VE Ticaret AS, 2021) has gone furthest, with 0 descendants of its own.
  • 2 other devices also cite its predicate K980695.

How does its category compare?

All EMA devices

EMA Cement, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · EMA

10in 2025

2007: 62008: 132009: 102010: 142011: 82012: 102013: 122014: 42015: 92016: 102017: 32018: 32019: 72020: 82021: 42022: 72023: 22024: 32025: 102026 (partial year): 7
2007high 14 (2010) · low 2 (2023)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EMA

106in 2025

2007: 48 days median2008: 71 days median2009: 86 days median2010: 86 days median2011: 79 days median2012: 128 days median2013: 178 days median2014: 174 days median2015: 134 days median2016: 182 days median2017: 141 days median2018: 237 days median2019: 127 days median2020: 164 days median2021: 184 days median2022: 245 days median2024: 59 days median2025: 106 days median2026 (partial year): 150 days median
2007high 245 (2022) · low 48 (2007)2026

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

Recalls per year · EMA

1in 2023

2008: 22009: 12010: 12011: 52023: 1
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

2007: 332008: 502009: 902010: 1062011: 2242012: 2492013: 3852014: 2072015: 852016: 162017: 132018: 42019: 122020: 52021: 82022: 32023: 62024: 52025: 9
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007648033
20081371250
20091086190
201014861106
20118795224
2012101280249
2013121780385
201441740207
20159134085
201610182016
20173141013
2018323704
20197127012
2020816405
2021418408
2022724503
20232—16
202435905
20251010609
202671500—

What is it indicated for?

ProGlass One: Cementation of all types of metal, porcelain fused to metal, resin crowns, inlays, onlays & bridges Cementation of orthodontic bands Cementation of stainless steel crowns or orthodontic appliances retained with stainless steel crowns Base/liner ProGlass Two: Class III, V and limited class I cavities Restoration of primary teeth Core Build Up ProGlass Two LC: Class III and V restorations Restoration of Cervical erosions and root surface…

Read the full statement (153 words)

ProGlass One: Cementation of all types of metal, porcelain fused to metal, resin crowns, inlays, onlays & bridges

Cementation of orthodontic bands

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

Base/liner

ProGlass Two: Class III, V and limited class I cavities

Restoration of primary teeth

Core Build Up

ProGlass Two LC: Class III and V restorations

Restoration of Cervical erosions and root surface canies

Core Build Up

Base/Liner

ProGlass Nine: Class I & II cavities

Decidious teeth: final restorative for Class I, II and V

Long term restorative in non-load bearing areas of Class I, II and V

Intermediate restorative & sandwich material for heavy stress bearing

Core build up material

ProGlass Plus: Metal-based restorations

Ceramic inlays

Reinforced ceramic crowns and bridges

All kinds of acrylic/resin crowns, inlays, onlays and bridges

ProGlass Silver: Class I, limited Class II, temporary fillings

Restoration of primary teeth

Core Build Up

Base/Liner

Indications for use as stated in the FDA summary.

Also cleared against K980695

2 other devices cite the same predicate.

  • K161851Glass Ionomer Cement (Luting)Shandong Huge Dental Material Corporation · 2016
  • K101420GC Fuji TempGC America, Inc. · 2010

More from Silmet, Ltd.

3 FDA decisions under this applicant name. See the company

  • K110403Prolink Adhesives (Prolink, Prolink SE)Silmet, Ltd. · 2011
  • K103190Profil Composites (Profil, Profil Flow)Silmet, Ltd. · 2011

Recent decisions in EMA

The EMA category page

  • K262983EsTemp ImplantSpident Co., Ltd. · 2026
  • K254201Any-CemMediclus Co., Ltd. · 2026
  • K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-Pak · 2026
  • K261166Dia-CemDiaDent Group International · 2026
  • K254109G-Cem UniversalGC America, Inc. · 2026

https://510kreport.com/device/K101869 · printed Nov 4, 2026

Cite this page

510(k) Report. “K101869: Proglass Cements (One, Two Two LC, Nine, Plus, Silver).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K101869

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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