510(k) · Cleared
ClearedKettosil and Silginat
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 Aug 6, 2008 as substantially equivalent to K070700 (Zhermack S.P.A., 2007) and 2 other predicates after a 6-day review. Its family tree reaches back 3 generations to 1981.
- Decided
- Aug 6, 2008
- Review
- 6 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K812116 (1981). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK812116 PermagumEspe-Premier Sales Co. · 1981
- 2 generations backK960547 Dimension Penta/Dimension Garant L/Polyvinyl Siloxane AdhesiveEspe GmbH & Co. Kg. · 1996
- 1 generation backK974231 Position Penta, Position Penta QuickEspe GmbH & Co. Kg. · 1998
- This deviceK082157 Kettosil and SilginatKettenbach GmbH & Co. KG · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K812116 | Permagum | Espe-Premier Sales Co. | 1981 | — |
| −2 | K960547 | Dimension Penta/Dimension Garant L/Polyvinyl Siloxane Adhesive | Espe GmbH & Co. Kg. | 1996 | — |
| −1 | K974231 | Position Penta, Position Penta Quick | Espe GmbH & Co. Kg. | 1998 | — |
| 0 (this device) | K082157 | Kettosil and Silginat | Kettenbach GmbH & Co. KG | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 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 |
|---|---|---|---|
| * | K070700 | FreealginSummary page 1…Material, Impression (21 CFR 827.3660, Product Code: ELW) C. Predicate Devices Trade Name: Freealgin, (K070700) Trade Name: Position Penta, Position Penta quick (K974231) Trade Name: Alg… | 2007 |
| * | K974231 | Position Penta, Position Penta QuickSummary page 1…Code: ELW) C. Predicate Devices Trade Name: Freealgin, (K070700) Trade Name: Position Penta, Position Penta quick (K974231) Trade Name: Alginot (Kerr VPS Impression Material) (K 050604) D. Device Description Kettosil® a… | 1998 |
| * | K050604 | Kerr VPS Impression MaterialSummary page 1…700) Trade Name: Position Penta, Position Penta quick (K974231) Trade Name: Alginot (Kerr VPS Impression Material) (K 050604) D. Device Description Kettosil® and Si/ginat® (Si/ginat®, Silginat® Strawberry) Impression Materials are addition-curin… | 2005 |
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 27 years and passes through 3 companies; a new generation was cleared every 10.5 years on median.
- 1 of the 6 ancestors has a recall of any class.
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?
Kettosil, Silginat and Silginat Strawberry are suitable for impressions in preparation of:
• Preliminary impression
• Anatomical models
• Fabricating temporary crowns and bridges
• Opposing dentition
• Fabricating simple removable prosthetic restorations
• Orthodontic work
• Fabricating removable retainers and splints
• Case study models
• Producing models for the construction of trays for whitening solutions, bites and surgical guides.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082157 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082157: Kettosil and Silginat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082157
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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