510(k) · Cleared
ClearedDytract Flow Restorative
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Intl. · EBF Material, Tooth Shade, Resin
Cleared on Aug 18, 1998 as substantially equivalent to K973235 (Dentsply Intl., 1998) and 1 other predicate after a 40-day review. Its family tree reaches back 2 generations to 1995. 3 later devices descend from it.
- Decided
- Aug 18, 1998
- Review
- 40 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K950991 (1995). 3 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK950991 Dyract II RestorativeDentsply Intl. · 1995
- 1 generation backK973235 Dyract AP RestorativeDentsply Intl. · 1998
- This deviceK982395 Dytract Flow RestorativeDentsply Intl. · 1998
- Descendant · cites it directly · 0 of its ownK041272 Dyract Cem Plus CementDentsply Intl. · 2004
- Descendant · cites it directly · 0 of its ownK993566 PromptflowEspe Dental AG · 1999
- Descendant · cites it directly · 0 of its ownK992516 Dyract Seal Compomer Pit & Fissure SealantDentsply Intl. · 1999
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K950991 | Dyract II Restorative | Dentsply Intl. | 1995 | — |
| −1 | K973235 | Dyract AP Restorative | Dentsply Intl. | 1998 | — |
| 0 (this device) | K982395 | Dytract Flow Restorative | Dentsply Intl. | 1998 | — |
| +1 | K041272 | Dyract Cem Plus Cement | Dentsply Intl. | 2004 | — |
| +1 | K993566 | Promptflow | Espe Dental AG | 1999 | — |
| +1 | K992516 | Dyract Seal Compomer Pit & Fissure Sealant | Dentsply Intl. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2004 | 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 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 |
|---|---|---|---|
| * | K973235 | Dyract AP RestorativeSummary page 1…® FLOW RESTORATIVE COMMON OR USUAL NAME: Dental restorative material CLASSIFICATION NAME: Tooth shade resin material 872.3690 PREDICATE DEVICE: Dyract® AP™ Restorative K973235 Aeliteflo Composite K955292 DEVICE DESCRIPTION: DYRACT® FLOW RESTORATIVE is a one-component, moderately filled, visible light cu… | 1998 |
| * | K955292 | AelitefloSummary page 1…R USUAL NAME: Dental restorative material CLASSIFICATION NAME: Tooth shade resin material 872.3690 PREDICATE DEVICE: Dyract® AP™ Restorative K973235 Aeliteflo Composite K955292 DEVICE DESCRIPTION: DYRACT® FLOW RESTORATIVE is a one-component, moderately filled, visible light cured dental composite restora… | 1995 |
What descends from it? (3)
3 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 3 years and passes through 1 company; a new generation was cleared every 2.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K041272 (Dentsply Intl., 2004) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K973235.
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?
Filling of defects and undercuts in crowns, inlays and onlays;
Liner under direct restorative materials and under inlay restorations——Class Il box liner;
Tunnel preparations;
Pit and fissure sealants;
Amalgam margin repair; Improving margins of acrylic temporaries;
Small class IV repairs;
Intraoral porcelain repair;
Cementing porcelain veneers, crowns, inlays/onlays;
Refacing acrylic temporaries;
Blockouts;
Covering incisal edge stains;
Repair of small enamel defects;
Provisional occlusal changes;
Class lll, V restorations;
Conservative Class | restorations;
Margin correction/adjustment of composite crowns for indirect laboratory use
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/K982395 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982395: Dytract Flow Restorative.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982395
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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