510(k) · Cleared
ClearedMiracle Mix Powder/Liquid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GC America, Inc. · EMA Cement, Dental
Cleared on Feb 4, 1999 after a 48-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Feb 4, 1999
- Review
- 48 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK984505 Miracle Mix Powder/LiquidGC America, Inc. · 1999
- Descendant · cites it directly · 3 of its ownK101869 Proglass Cements (One, Two Two LC, Nine, Plus, Silver)Silmet, Ltd. · 2010
- Descendant · 2 generations on · 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
- Descendant · 2 generations on · 0 of its ownK200555 Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior…Prevest Denpro Limited · 2021
- Descendant · 2 generations on · 0 of its ownK123824 Vitro Fil LCDfl Industria E Comercio SA · 2013
Most influential descendants
Showing 4 of 4 · See all- K101869Proglass Cements (One, Two Two LC, Nine, Plus, Silver)Silmet, Ltd. · 2010 · cites it directly3descendants
- 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 · 2 generations on0descendants
- K200555Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior…Prevest Denpro Limited · 2021 · 2 generations on0descendants
- K123824Vitro Fil LCDfl Industria E Comercio SA · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K984505 | Miracle Mix Powder/Liquid | GC America, Inc. | 1999 | — |
| +1 | K101869 | Proglass Cements (One, Two Two LC, Nine, Plus, Silver) | Silmet, Ltd. | 2010 | — |
| +2 | K210473 | Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF… | Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | 2021 | — |
| +2 | K200555 | Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron… | Prevest Denpro Limited | 2021 | — |
| +2 | K123824 | Vitro Fil LC | Dfl Industria E Comercio SA | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2021 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101869 | Proglass Cements (One, Two Two LC, Nine, Plus, Silver) | 2010 | 3 |
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?
- Of its descendants, K101869 (Silmet, Ltd., 2010) has gone furthest, with 3 descendants of its own.
How does its category compare?
All EMA devicesEMA Cement, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Miracle Mix is a powder and liquid self cure silver alloy glass ionomer cement intended for core build ups, restoration of primary teeth, as a base or a liner, for Class I, limited class I, temporary fillings and in cases where radiopacity is required.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K984505 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984505: Miracle Mix Powder/Liquid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984505
Report an extraction error
Are you the manufacturer?
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