510(k) · Cleared
ClearedPackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gaia Dental Products, Inc. · EMA Cement, Dental
Cleared on Apr 5, 2016 as substantially equivalent to K051427 (GC America, Inc., 2005) and 1 other predicate after a 202-day review. Its family tree reaches back 2 generations to 1992.
- Decided
- Apr 5, 2016
- Review
- 202 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K925032 (1992). 5 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K925032 | 3M Vitremer Tri-Cure Glass Ionomer System | 3M Company | 1992 | — |
| −1 | K052235 | LCR | 3M Company | 2005 | — |
| 0 (this device) | K152652 | PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement | Gaia Dental Products, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2000 | 1 | 0 |
| 2005 | 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? (2)
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 |
|---|---|---|---|
| * | K051427 | GC Fuji Fil LCSummary page 4…§ 872.3275 • Additional Product Code – EBF, Tooth Shade Resin Material Devices for Which Substantial Equivalence is Claimed: Primary Predicate: GC, Fuji Filling LC; K051427 Reference Predicate: 3M ESPE, Ketac Nano Glass Ionomer Restorative; K 052235 Device Description: PackFil Resin Modified Glass… | 2005 |
| * | K052235 | LCRSummary page 4…vices for Which Substantial Equivalence is Claimed: Primary Predicate: GC, Fuji Filling LC; K051427 Reference Predicate: 3M ESPE, Ketac Nano Glass Ionomer Restorative; K 052235 Device Description: PackFil Resin Modified Glass Ionomer (RMGI) Restorative Cement is used by dental professionals and intended… | 2005 |
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 24 years and passes through 2 companies; a new generation was cleared every 12.8 years on median.
- None of the 5 ancestors has a recall.
- 3 other devices also cite its predicate K051427.
How does its category compare?
All EMA devicesEMA 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
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?
PackFil RMGI Restorative Cement is indicated for filling and restoration of tooth of following typical applications:
• Primary teeth restorations;
• Class I restorations;
• Class III and V restorations;
• Transitional restorations;
• Base liners or laminated/sandwich restorations;
• Selective core build-ups (>50% coronal tooth intact);
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/K152652 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152652: PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152652
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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