510(k) · Cleared
ClearedStoneBite and StoneBite scan
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dreve Dentamid GmbH · ELW Material, Impression
Cleared on Nov 7, 2019 as substantially equivalent to K081120 (Kettenbach GmbH & Co. KG, 2008) after a 246-day review. Its family tree reaches back 2 generations to 1996. 1 later device descends from it.
- Decided
- Nov 7, 2019
- Review
- 246 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K954281 (1996). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK954281 Panasil Impression MaterialRoydent Dental Products, Inc. · 1996
- 1 generation backK081120 Futar (Futar, Futar D, Futar D Fast, Futar D Slow, Futar Scan Bite…Kettenbach GmbH & Co. KG · 2008
- This deviceK190571 StoneBite and StoneBite scanDreve Dentamid GmbH · 2019
- Descendant · cites it directly · 0 of its ownK250969 Jet Bite; Jet Blue Bite Fast; Jet Blue Bite SuperfastDent4you AG · 2025
Most influential descendants
Showing 1 of 1 · See all- K250969Jet Bite; Jet Blue Bite Fast; Jet Blue Bite SuperfastDent4you AG · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K954281 | Panasil Impression Material | Roydent Dental Products, Inc. | 1996 | — |
| −1 | K081120 | Futar (Futar, Futar D, Futar D Fast, Futar D Slow, Futar Scan Bite… | Kettenbach GmbH & Co. KG | 2008 | — |
| 0 (this device) | K190571 | StoneBite and StoneBite scan | Dreve Dentamid GmbH | 2019 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K081120 | Futar (Futar, Futar D, Futar D Fast, Futar D Slow, Futar Scan Bite Registration MaterialsSummary page 4…ression Material Regulation Number 21 CFR 872.3660 Product Code ELW Predicate Devices Futar® (Kettenbach GmbH & Co. KG) – K081120 – Primary Predicate StoneBite© and StoneBite© scan - 510(k) Premarket Notification Page 1 === Page 5 ==… | 2008 |
| † | K171562 | Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono | 2018 |
| † | K081017 | Template and Counter-Fit | 2008 |
| † | K021410 | Aquasil Ultra XLV Smart Wetting Impression Material | 2002 |
| † | K053427 | Fresh, Dental Impression Material | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250969 | Jet Bite; Jet Blue Bite Fast; Jet Blue Bite Superfast | 2025 | 0 |
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 23 years and passes through 3 companies; a new generation was cleared every 11.9 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K250969 (Dent4you AG, 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K081120.
How does its category compare?
All ELW devicesELW Material, Impression: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
StoneBite© and StoneBite© scan are addition-curing silicones for bite registrations.
StoneBite© is indicated for:
▪ bite registrations
▪ key for intraoral registration
StoneBite© scan is indicated for:
▪ bite registrations
▪ key for intraoral registration
▪ optical collection of data in CAD/CAM/CIM systems
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190571 · printed Nov 4, 2026
Cite this page
510(k) Report. “K190571: StoneBite and StoneBite scan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190571
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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