510(k) · Cleared
ClearedNova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imicryl Dis Malzemeleri Sanayi VE Ticaret AS · EMA Cement, Dental
Cleared on Nov 2, 2021 as substantially equivalent to K101869 (Silmet, Ltd., 2010) after a 258-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Nov 2, 2021
- Review
- 258 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.
- 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 deviceK210473 Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova…Imicryl Dis Malzemeleri Sanayi VE Ticaret AS · 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) | K210473 | Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF… | Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K101869 | Proglass Cements (One, Two Two LC, Nine, Plus, Silver)Summary page 6…rketed product: COMPANY DEVICE 510(k) NUMBER PRODUCT CODE Silmet Ltd. ProGlass Cements (ProGlass One, K101869 EMA ProGlass Two, ProGlass Two LC, ProGlass (Primary Predicate) Nine, ProGlass Plus,… | 2010 |
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 devicesEMA 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
2026 to Oct 25, outlined.
Median 510(k) review, days · EMA
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EMA
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EMA
9in 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?
Nova Glass L -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 Nova Glass F -Class III, V and limited class I cavities -Restoration of primary teeth -Core Build Up Nova Glass LC -Class III and V restorations -Restoration of Cervical erosions and root surface…
Read the full statement (141 words)
Nova Glass L -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
Nova Glass F -Class III, V and limited class I cavities
-Restoration of primary teeth
-Core Build Up
Nova Glass LC -Class III and V restorations
-Restoration of Cervical erosions and root surface caries
-Core build up
-Base/liner
Nova Glass BF -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
Nova Glass L Plus -Metal-based restorations
-Ceramic inlays
-Reinforced ceramic crowns and bridges
-All kinds of acrylic/resin crowns, inlays, onlays and bridges
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210473 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210473: Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210473
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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