510(k) · Cleared
ClearedJet Bite; Jet Blue Bite Fast; Jet Blue Bite Superfast
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dent4you AG · ELW Material, Impression
Cleared on Jun 27, 2025 as substantially equivalent to K190571 (Dreve Dentamid GmbH, 2019) after an 88-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Jun 27, 2025
- Review
- 88 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K954281 (1996). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK954281 Panasil Impression MaterialRoydent Dental Products, Inc. · 1996
- 2 generations backK081120 Futar (Futar, Futar D, Futar D Fast, Futar D Slow, Futar Scan Bite…Kettenbach GmbH & Co. KG · 2008
- 1 generation backK190571 StoneBite and StoneBite scanDreve Dentamid GmbH · 2019
- This deviceK250969 Jet Bite; Jet Blue Bite Fast; Jet Blue Bite SuperfastDent4you AG · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K954281 | Panasil Impression Material | Roydent Dental Products, Inc. | 1996 | — |
| −2 | K081120 | Futar (Futar, Futar D, Futar D Fast, Futar D Slow, Futar Scan Bite… | Kettenbach GmbH & Co. KG | 2008 | — |
| −1 | K190571 | StoneBite and StoneBite scan | Dreve Dentamid GmbH | 2019 | — |
| 0 (this device) | K250969 | Jet Bite; Jet Blue Bite Fast; Jet Blue Bite Superfast | Dent4you AG | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 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 ELW? 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 ELW device
- #1 K254152 Dia-X Sil Light Bodyscore 14.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K190571 | StoneBite and StoneBite scanSummary page 5…r 872.3660 Product Code(s) ELW I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K190571 StoneBite and StoneBite scan ELW Device Description Summary 21 CFR 807.92(a)(4) Jet Bite and Jet Blue Bite are two component imp… | 2019 |
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 29 years and passes through 4 companies; a new generation was cleared every 11.5 years on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All ELW devicesELW Material, Impression: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · ELW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ELW
98in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ELW
3in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ELW
22in 2025
MAUDE reports naming product code ELW, 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 | 7 | 60 | 0 | 9 |
| 2008 | 11 | 30 | 0 | 17 |
| 2009 | 7 | 43 | 0 | 7 |
| 2010 | 5 | 88 | 1 | 16 |
| 2011 | 9 | 83 | 0 | 15 |
| 2012 | 7 | 87 | 1 | 14 |
| 2013 | 5 | 67 | 3 | 32 |
| 2014 | 11 | 122 | 0 | 35 |
| 2015 | 8 | 93 | 0 | 18 |
| 2016 | 7 | 166 | 3 | 15 |
| 2017 | 3 | 89 | 0 | 17 |
| 2018 | 5 | 126 | 0 | 14 |
| 2019 | 2 | — | 0 | 24 |
| 2020 | 4 | 99 | 0 | 8 |
| 2021 | 3 | 76 | 0 | 6 |
| 2022 | 7 | 60 | 0 | 9 |
| 2023 | 2 | — | 0 | 13 |
| 2024 | 3 | 98 | 0 | 3 |
| 2025 | 2 | — | 0 | 22 |
| 2026 | 3 | 268 | 0 | — |
What is it indicated for?
JET BITE & JET BLUE BITE are intended for the registration of occlusion in cases where relationship between the relative positions of maxilla and mandible is required.
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/K250969 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250969: Jet Bite; Jet Blue Bite Fast; Jet Blue Bite Superfast.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250969
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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