510(k) · Cleared
ClearedPhoglass Fill, Core, Cem, Seal, Prime and Phoglass Protect
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
S & C Polymer GmbH · EMA Cement, Dental
Cleared on Jan 15, 2009 after a 171-day review. The FDA summary names its predicate without a number.
- Decided
- Jan 15, 2009
- Review
- 171 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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? (4)
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 |
|---|---|---|---|
| * | — | Fuji IXGP Extra Named without a submission number | |
| * | — | Fuji VII Named without a submission number | |
| * | — | GC Dentin Conditioner Named without a submission number | |
| * | — | GC Fuji Varnish Named without a submission number |
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.
How does its category compare?
All EMA devicesEMA Cement, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
PhoGlass Fill is intended to be used as an insoluble filling cement for uniplanar fillings of class 1,III and V cavities, for primary tooth fillings, for linings of composite fillings and also for core build-ups. PhoGlass Core is intended to be used as an insoluble core build-up cement and for underlinings of composite fillings. PhoGlass Seal is intended to be used as an insoluble sealing cement for hypersensitivity prevention and control, for root…
Read the full statement (121 words)
PhoGlass Fill is intended to be used as an insoluble filling cement for uniplanar fillings of class 1,III and V cavities, for primary tooth fillings, for linings of composite fillings and also for core build-ups.
PhoGlass Core is intended to be used as an insoluble core build-up cement and for underlinings of composite fillings.
PhoGlass Seal is intended to be used as an insoluble sealing cement for hypersensitivity prevention and control, for root surface protection, for fissure protection and for intermediate restorations of lesions.
PhoGlass Prime is intended to be used as a conditioner for dentin and enamel to enhance the bond between the cements and the tooth structure.
PhoGlass Protect is intended for protecting PhoGlass restorations from exposure to moisture.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082115 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082115: Phoglass Fill, Core, Cem, Seal, Prime and Phoglass Protect.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082115
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026