510(k) · Cleared
ClearedLascod Impression Materials
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lascod Spa · ELW Material, Impression
Cleared on May 5, 2020 as substantially equivalent to K170736 (Osstem Implant Co., Ltd., 2017) after a 4-day review. Its family tree reaches back 7 generations to 1994.
- Decided
- May 5, 2020
- Review
- 4 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K943574 (1994). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK943574 Capture Impression MaterialDentsply Intl. · 1994
- 6 generations backK973782 Aquasil XLV Smart Wetting Impression MaterialDentsply Intl. · 1997
- 5 generations backK021410 Aquasil Ultra XLV Smart Wetting Impression MaterialDentsply Intl. · 2002
- 4 generations backK082560 Panasil Impression Materials, Including Putty, Binetics, Tray…Kettenbach GmbH & Co. KG · 2008
- 3 generations backK133527 Suflex Putty, Suflex Heavy, Suflex Mono, Suflex LightOsstem Germany GmbH · 2014
- 2 generations backK151262 Hyflex Heavy, Hyflex Mono, Hyflex LightOsstem Implant Co., Ltd. · 2015
- 1 generation backK170736 HySil Impression MaterialsOsstem Implant Co., Ltd. · 2017
- This deviceK201184 Lascod Impression MaterialsLascod Spa · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K943574 | Capture Impression Material | Dentsply Intl. | 1994 | — |
| −6 | K973782 | Aquasil XLV Smart Wetting Impression Material | Dentsply Intl. | 1997 | — |
| −5 | K021410 | Aquasil Ultra XLV Smart Wetting Impression Material | Dentsply Intl. | 2002 | — |
| −4 | K082560 | Panasil Impression Materials, Including Putty, Binetics, Tray, Monophase and… | Kettenbach GmbH & Co. KG | 2008 | — |
| −3 | K133527 | Suflex Putty, Suflex Heavy, Suflex Mono, Suflex Light | Osstem Germany GmbH | 2014 | — |
| −2 | K151262 | Hyflex Heavy, Hyflex Mono, Hyflex Light | Osstem Implant Co., Ltd. | 2015 | — |
| −1 | K170736 | HySil Impression Materials | Osstem Implant Co., Ltd. | 2017 | — |
| 0 (this device) | K201184 | Lascod Impression Materials | Lascod Spa | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2002 | 2 | 0 |
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K170736 | HySil Impression MaterialsSummary page 4…Email: [email protected] 5. Predicate Device HySil Impression Materials 510k number K170736 Common Name Impression Material Classification Name Material, Impression R… | 2017 |
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 26 years and passes through 5 companies; a new generation was cleared every 3.3 years on median.
- 1 of the 14 ancestors has a recall of any class.
- 5 other devices also cite its predicate K170736.
How does its category compare?
All ELW devicesELW Material, Impression: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
The Lascod family of silicone impression materials includes the brand names: Ghenesyl, Kromopan Sil are used by dentists to take the anatomical data of the patient's mouth and subsequently realize a plaster mold useful to diagnose problems, define required interventions, and/or check their effectiveness. The Ghenesyl Putty and Kromopan Sil Putty products are indicated for obtaining preliminary impressions for the two-step putty/wash and base for the…
Read the full statement (209 words)
The Lascod family of silicone impression materials includes the brand names: Ghenesyl, Kromopan Sil are used by dentists to take the anatomical data of the patient's mouth and subsequently realize a plaster mold useful to diagnose problems, define required interventions, and/or check their effectiveness.
The Ghenesyl Putty and Kromopan Sil Putty products are indicated for obtaining preliminary impressions for the two-step putty/wash and base for the sandwich technique. The impression can be electroplated.
The Ghenesyl Body and Kromopan Sil Body products are indicated for the two-step putty/wash and for the sandwich technique. The impression can be electroplated.
The Ghenesyl Mono and Kromopan Sil mono products are indicated for monophasic technique, though it can be used also with Super Light Body / Light Body / Regular Body wash silicones as support material inside individual impression tray or standard stainless-steel impression tray.
Kromopan Sil Bite and Oklurest used by dentists to take impressions of occlusal surfaces in order to confirm the occlusal surfaces onto the plaster models assembled on an articulator.
Kromopan Sil Bite and Oklurest and products are indicated for orthodontic occlusion registration, registration keys for gnathological registrations, inter-maxillary registration keys for centered positions, eruptions and ectopic eruptions, registration for cephalometric analysis which also require subsequent scanning with CAD systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201184 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201184: Lascod Impression Materials.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201184
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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