510(k) · Cleared
ClearedDeltaFil, DeltaFil Conditioner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DMG Chemisch-Pharmazeutische Fabrik GmbH · EMA Cement, Dental
Cleared on Jun 1, 2022 as substantially equivalent to K961448 (GC America, Inc., 1996) and 1 other predicate after a 245-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- Jun 1, 2022
- Review
- 245 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K872984 (1988). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK872984 Ketac-ConditionerEspe GmbH (Us) · 1988
- This deviceK213201 DeltaFil, DeltaFil ConditionerDMG Chemisch-Pharmazeutische Fabrik GmbH · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K872984 | Ketac-Conditioner | Espe GmbH (Us) | 1988 | — |
| 0 (this device) | K213201 | DeltaFil, DeltaFil Conditioner | DMG Chemisch-Pharmazeutische Fabrik GmbH | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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 |
|---|---|---|---|
| * | K961448 | Fuji IX GPSummary page 4…EMA Regulation: 21 CFR 872.3275 (Dental Cement) Device Classification: II Premarket Notification: K961448 Trade Name: Ketac Conditioner (3M ESPE GmbH) Common/Usual Name: Tooth Conditioner… | 1996 |
| * | K872984 | Ketac-ConditionerSummary page 4…EMA Regulation: 21 CFR 872.3275 (Dental Cement) Device Classification: II Premarket Notification: K872984 Reference Device: Trade Name: DiaEtch (Diadent Group International) Common/Usual Name:… | 1988 |
| † | K192273 | DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A… | 2020 |
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?
- None of the 2 ancestors has a recall.
- 3 other devices also cite its predicate K961448.
How does its category compare?
All EMA devicesEMA Cement, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
DeltaFil (in capsule) is used for geriatric and pediatric restorative filling procedures. The product is designed for use in final restorations of Class I, II, III, and V of deciduous teeth and as a long - term restorative in non-load bearing areas of Class I and II carious lesions. It is also used as a restorative and sandwich material for heavy stress in Class I and II cavities. DeltaFil can also be used as a core build-up material.
DeltaFil Conditioner:
• Treatment of the smear layer
• Conditioning of the cavity
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213201 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213201: DeltaFil, DeltaFil Conditioner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213201
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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