510(k) · Cleared
ClearedFutar (Futar, Futar D, Futar D Fast, Futar D Slow, Futar Scan Bite Registration Materials
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kettenbach GmbH & Co. KG · ELW Material, Impression
Cleared on May 1, 2008 as substantially equivalent to K954281 (Roydent Dental Products, Inc., 1996) and 2 other predicates after a 10-day review. Its family tree reaches back 1 generation to 1996. 3 later devices descend from it.
- Decided
- May 1, 2008
- Review
- 10 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K954281 (1996). 3 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK954281 Panasil Impression MaterialRoydent Dental Products, Inc. · 1996
- This deviceK081120 Futar (Futar, Futar D, Futar D Fast, Futar D Slow, Futar Scan Bite…Kettenbach GmbH & Co. KG · 2008
- Descendant · cites it directly · 1 of its ownK190571 StoneBite and StoneBite scanDreve Dentamid GmbH · 2019
- Descendant · 2 generations on · 0 of its ownK250969 Jet Bite; Jet Blue Bite Fast; Jet Blue Bite SuperfastDent4you AG · 2025
- Descendant · cites it directly · 0 of its ownK113279 Identium Heavy, Identium Medium, Identium Scan Heavy, Identium Scan…Kettenbach GmbH & Co. KG · 2011
Most influential descendants
Showing 3 of 3 · See all- K190571StoneBite and StoneBite scanDreve Dentamid GmbH · 2019 · cites it directly1descendant
- K250969Jet Bite; Jet Blue Bite Fast; Jet Blue Bite SuperfastDent4you AG · 2025 · 2 generations on0descendants
- K113279Identium Heavy, Identium Medium, Identium Scan Heavy, Identium Scan Medium, Identium…Kettenbach GmbH & Co. KG · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954281 | Panasil Impression Material | Roydent Dental Products, Inc. | 1996 | — |
| 0 (this device) | 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 | — |
| +2 | K250969 | Jet Bite; Jet Blue Bite Fast; Jet Blue Bite Superfast | Dent4you AG | 2025 | — |
| +1 | K113279 | Identium Heavy, Identium Medium, Identium Scan Heavy, Identium Scan Medium… | Kettenbach GmbH & Co. KG | 2011 | — |
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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2019 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K954281 | Panasil Impression MaterialSummary page 1…1 CFR 827.3660, Product Code: ELW) C. Predicate Devices Trade Name: Futar® Occlusion, Futar® D Occlusion (K954281) Trade Name: R-SI-LINE® METAL-BITE® (K01 0926) Trade Name: Mega Bite Registrati… | 1996 |
| * | K010926 | R-SI-Line Metal-BiteSummary page 1…) C. Predicate Devices Trade Name: Futar® Occlusion, Futar® D Occlusion (K954281) Trade Name: R-SI-LINE® METAL-BITE® (K01 0926) Trade Name: Mega Bite Registration (K030776) D. Device Description Futar®,Futar®D, Futar®D Fast,… | 2001 |
| * | K030776 | Mega Bite Registration - Dental Bite Registration MaterialSummary page 1…clusion, Futar® D Occlusion (K954281) Trade Name: R-SI-LINE® METAL-BITE® (K01 0926) Trade Name: Mega Bite Registration (K030776) D. Device Description Futar®,Futar®D, Futar®D Fast, Futar®D Slow, and Futar®Scan are syringeable, addition-curing, ela… | 2003 |
What descends from it? (3)
2 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?
How does its category compare?
All ELW devicesELW Material, Impression: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
All Futar bite registration materials (Futar, FutarD, FutarD Fast, FutarD Slow, FutarScan) can be used for making accurate occlusal registrations.
Futar D materials (FutarD, FutarD Fast, FutarD Slow) can be used for applications, which require a hard bite registration silicone.
FutarD Fast can be used for "small applications" because of its shorter working time.
FutarD Slow can be used for time-consuming bite registrations because of its longer working time.
FutarScan can also be used for an optical registration of occlusal data for CAD/CAM/CIM systems without using powder.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081120 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081120: Futar (Futar, Futar D, Futar D Fast, Futar D Slow, Futar Scan Bite Registration Materials.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081120
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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