510(k) · Cleared
ClearedPromptflow
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Espe Dental AG · EBF Material, Tooth Shade, Resin
Cleared on Dec 6, 1999 as substantially equivalent to K992966 (Espe Dental AG, 1999) and 1 other predicate after a 46-day review. Its family tree reaches back 5 generations to 1990.
- Decided
- Dec 6, 1999
- Review
- 46 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K900510 (1990). 17 ancestors in all, the oldest K843566 (1984). No later device cites it as a predicate yet.
- Root · 5 generations backK900510 Pertac-HybridEspe GmbH (Us) · 1990
- 4 generations backK962440 Pertac II/Pertac II AplitipEspe GmbH & Co. Kg. · 1996
- 3 generations backK974458 Compolute AplicapEspe Dental-Medizin GmbH & Co.Kg. · 1998
- 2 generations backK984246 Prompt L-PopEspe Dental AG · 1999
- 1 generation backK992966 ReferenceEspe Dental AG · 1999
- This deviceK993566 PromptflowEspe Dental AG · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K900510 | Pertac-Hybrid | Espe GmbH (Us) | 1990 | — |
| −4 | K962440 | Pertac II/Pertac II Aplitip | Espe GmbH & Co. Kg. | 1996 | — |
| −3 | K974458 | Compolute Aplicap | Espe Dental-Medizin GmbH & Co.Kg. | 1998 | — |
| −2 | K984246 | Prompt L-Pop | Espe Dental AG | 1999 | — |
| −1 | K992966 | Reference | Espe Dental AG | 1999 | — |
| 0 (this device) | K993566 | Promptflow | Espe Dental AG | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 2 | 0 |
| 1998 | 2 | 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 EBF? 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 EBF device
- #1 K202846 Tera Harzscore 18.5 · 7 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 |
|---|---|---|---|
| * | K992966 | ReferenceSummary page 1…ennnnn. Tooth shade resin material Common Name:.....ccooeeriivemmiinieiincneens Composite restorative material Predicate Device REFERENCE® by ESPE........ccccovvvveee. K 992966 DYRACT® FLOW by Dentsply................. K 982395 Description for the Premarket Notification PROMPTFLOW® is classified as toot… | 1999 |
| * | K982395 | Dytract Flow RestorativeSummary page 1….ccooeeriivemmiinieiincneens Composite restorative material Predicate Device REFERENCE® by ESPE........ccccovvvveee. K 992966 DYRACT® FLOW by Dentsply................. K 982395 Description for the Premarket Notification PROMPTFLOW® is classified as tooth shade resin material (21 C.F.R. § 872.3660) becau… | 1998 |
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 9 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- None of the 17 ancestors has a recall.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EBF
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBF
43in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBF
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBF
1in 2025
MAUDE reports naming product code EBF, 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 | 19 | 49 | 1 | 6 |
| 2008 | 14 | 79 | 42 | 10 |
| 2009 | 20 | 84 | 1 | 8 |
| 2010 | 19 | 75 | 6 | 31 |
| 2011 | 19 | 81 | 7 | 31 |
| 2012 | 11 | 86 | 0 | 62 |
| 2013 | 13 | 153 | 0 | 246 |
| 2014 | 10 | 112 | 0 | 195 |
| 2015 | 17 | 123 | 0 | 119 |
| 2016 | 20 | 205 | 0 | 143 |
| 2017 | 15 | 108 | 4 | 42 |
| 2018 | 15 | 115 | 0 | 8 |
| 2019 | 17 | 159 | 2 | 11 |
| 2020 | 15 | 190 | 1 | 2 |
| 2021 | 13 | 178 | 0 | 2 |
| 2022 | 17 | 63 | 0 | 2 |
| 2023 | 9 | 87 | 0 | 8 |
| 2024 | 18 | 120 | 0 | 5 |
| 2025 | 15 | 43 | 0 | 1 |
| 2026 | 16 | 59 | 2 | — |
What is it indicated for?
Flowable composite restorative material for:
Minimally-invasive fillings
Restorations of type II and V cavities (according to Black)
Liner for restorations of type I and II cavities
Small restorations of type I and II cavities
Deciduous tooth fillings
Fissure sealing
Extended fissure sealing
Tunnel preparation
Repair of composite fillings and ceramic veneers
Filling of defects and undercuts in crowns, inlays, and onlays
Cementing porcelain veneers, crowns, inlays, and onlays
Refacing acrylic temporaries
Blockouts
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/K993566 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993566: Promptflow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993566
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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