510(k) · Cleared
ClearedPrompt L-Pop
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Espe Dental AG · KLE Agent, Tooth Bonding, Resin
Cleared on Jan 8, 1999 as substantially equivalent to K962442 (Espe GmbH & Co. Kg., 1996) and 2 other predicates after a 42-day review. Its family tree reaches back 3 generations to 1990. 5 later devices descend from it.
- Decided
- Jan 8, 1999
- Review
- 42 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K900510 (1990). 8 ancestors in all. 5 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK900510 Pertac-HybridEspe GmbH (Us) · 1990
- 2 generations backK962440 Pertac II/Pertac II AplitipEspe GmbH & Co. Kg. · 1996
- 1 generation backK974458 Compolute AplicapEspe Dental-Medizin GmbH & Co.Kg. · 1998
- This deviceK984246 Prompt L-PopEspe Dental AG · 1999
- Descendant · cites it directly · 1 of its ownK992966 ReferenceEspe Dental AG · 1999
- Descendant · cites it directly · 0 of its ownK210945 Ultra SEPReliance Orthodontic Products, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK071688 Reliance S.E.P.Reliance Orthodontic Products, Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK993566 PromptflowEspe Dental AG · 1999
- Descendant · cites it directly · 0 of its ownK992048 Modification of Prompt L-PopEspe Dental AG · 1999 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K992966ReferenceEspe Dental AG · 1999 · cites it directly1descendant
- K210945Ultra SEPReliance Orthodontic Products, Inc. · 2021 · cites it directly0descendants
- K071688Reliance S.E.P.Reliance Orthodontic Products, Inc. · 2007 · cites it directly0descendants
- K993566PromptflowEspe Dental AG · 1999 · 2 generations on0descendants
- K992048Modification of Prompt L-PopEspe Dental AG · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K900510 | Pertac-Hybrid | Espe GmbH (Us) | 1990 | — |
| −2 | K962440 | Pertac II/Pertac II Aplitip | Espe GmbH & Co. Kg. | 1996 | — |
| −1 | K974458 | Compolute Aplicap | Espe Dental-Medizin GmbH & Co.Kg. | 1998 | — |
| 0 (this device) | K984246 | Prompt L-Pop | Espe Dental AG | 1999 | — |
| +1 | K992966 | Reference | Espe Dental AG | 1999 | — |
| +1 | K210945 | Ultra SEP | Reliance Orthodontic Products, Inc. | 2021 | — |
| +1 | K071688 | Reliance S.E.P. | Reliance Orthodontic Products, Inc. | 2007 | — |
| +2 | K993566 | Promptflow | Espe Dental AG | 1999 | — |
| +1 | K992048 | Modification of Prompt L-Pop | Espe Dental AG | 1999 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 3 | 0 |
| 2007 | 1 | 0 |
| 2021 | 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 KLE? 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 KLE device
- #1 K262252 MPa Max adhesivescore 15.1 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K962442 | Hytac Aplitip/Hytac OsbSummary page 1…assification Name:.............. Resin Tooth Bonding Agent Common Name: ...cccccceevrennne Compomer Bonding Agent Predicate Devices HYTAC® OSB by ESPE................ (K962442) HYDROGUM® by Zhermack...... (K935898) COMPOLUTE® by ESPE............... (K974458) Description for the Premarket Notification PR… | 1996 |
| * | K935898 | HydrogumSummary page 1…Tooth Bonding Agent Common Name: ...cccccceevrennne Compomer Bonding Agent Predicate Devices HYTAC® OSB by ESPE................ (K962442) HYDROGUM® by Zhermack...... (K935898) COMPOLUTE® by ESPE............... (K974458) Description for the Premarket Notification PROMPT® L-POP® is classified as a Resin… | 1995 |
| * | K974458 | Compolute AplicapSummary page 1…evrennne Compomer Bonding Agent Predicate Devices HYTAC® OSB by ESPE................ (K962442) HYDROGUM® by Zhermack...... (K935898) COMPOLUTE® by ESPE............... (K974458) Description for the Premarket Notification PROMPT® L-POP® is classified as a Resin Tooth Bonding Agent (21 C.F.R. § 872.3200) b… | 1998 |
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 1.4 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K992966 (Espe Dental AG, 1999) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K962442.
How does its category compare?
All KLE devicesKLE Agent, Tooth Bonding, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KLE
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KLE
149in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KLE
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KLE
3in 2025
MAUDE reports naming product code KLE, 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 | 14 | 71 | 2 | 18 |
| 2008 | 3 | 66 | 0 | 9 |
| 2009 | 7 | 79 | 1 | 11 |
| 2010 | 8 | 93 | 1 | 13 |
| 2011 | 10 | 100 | 0 | 69 |
| 2012 | 5 | 66 | 0 | 176 |
| 2013 | 11 | 115 | 0 | 248 |
| 2014 | 6 | 120 | 0 | 260 |
| 2015 | 10 | 118 | 0 | 100 |
| 2016 | 3 | 148 | 1 | 47 |
| 2017 | 4 | 171 | 1 | 42 |
| 2018 | 8 | 124 | 0 | 31 |
| 2019 | 6 | 143 | 0 | 20 |
| 2020 | 6 | 195 | 0 | 6 |
| 2021 | 4 | 163 | 0 | 6 |
| 2022 | 8 | 98 | 0 | 7 |
| 2023 | 6 | 75 | 0 | 7 |
| 2024 | 7 | 61 | 1 | 12 |
| 2025 | 3 | 149 | 0 | 3 |
| 2026 | 7 | 84 | 0 | — |
What is it indicated for?
Bonding of Enamel/Dentin and Compomer Restorative Materials
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/K984246 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984246: Prompt L-Pop.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984246
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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