510(k) · Cleared
ClearedHySil Impression Materials
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osstem Implant Co., Ltd. · ELW Material, Impression
Cleared on Jun 7, 2017 as substantially equivalent to K133527 (Osstem Germany GmbH, 2014) and 2 other predicates after an 89-day review. Its family tree reaches back 6 generations to 1994. 10 later devices descend from it.
- Decided
- Jun 7, 2017
- Review
- 89 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K943574 (1994). 13 ancestors in all. 10 later devices descend from it, 6 citing it directly.
- Root · 6 generations backK943574 Capture Impression MaterialDentsply Intl. · 1994
- 5 generations backK973782 Aquasil XLV Smart Wetting Impression MaterialDentsply Intl. · 1997
- 4 generations backK021410 Aquasil Ultra XLV Smart Wetting Impression MaterialDentsply Intl. · 2002
- 3 generations backK082560 Panasil Impression Materials, Including Putty, Binetics, Tray…Kettenbach GmbH & Co. KG · 2008
- 2 generations backK133527 Suflex Putty, Suflex Heavy, Suflex Mono, Suflex LightOsstem Germany GmbH · 2014
- 1 generation backK151262 Hyflex Heavy, Hyflex Mono, Hyflex LightOsstem Implant Co., Ltd. · 2015
- This deviceK170736 HySil Impression MaterialsOsstem Implant Co., Ltd. · 2017
- Descendant · cites it directly · 2 of its ownK214086 Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy…Genoss Co., Ltd. · 2022
- Descendant · cites it directly · 2 of its ownK192941 HySil Super Fast Impression MaterialsOsstem Implant Co., Ltd. · 2020
- Descendant · cites it directly · 1 of its ownK181236 HySil Impression MaterialsOsstem Implant Co., Ltd. · 2018
- Descendant · 2 generations on · 0 of its ownK254152 Dia-X Sil Light BodyDiaDent Group International · 2026
- Descendant · 2 generations on · 0 of its ownK254142 Dia-X Sil Heavy BodyDiaDent Group International · 2026
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K214086Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite…Genoss Co., Ltd. · 2022 · cites it directly2descendants
- K192941HySil Super Fast Impression MaterialsOsstem Implant Co., Ltd. · 2020 · cites it directly2descendants
- K181236HySil Impression MaterialsOsstem Implant Co., Ltd. · 2018 · cites it directly1descendant
- K254152Dia-X Sil Light BodyDiaDent Group International · 2026 · 2 generations on0descendants
- K254142Dia-X Sil Heavy BodyDiaDent Group International · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K943574 | Capture Impression Material | Dentsply Intl. | 1994 | — |
| −5 | K973782 | Aquasil XLV Smart Wetting Impression Material | Dentsply Intl. | 1997 | — |
| −4 | K021410 | Aquasil Ultra XLV Smart Wetting Impression Material | Dentsply Intl. | 2002 | — |
| −3 | K082560 | Panasil Impression Materials, Including Putty, Binetics, Tray, Monophase and… | Kettenbach GmbH & Co. KG | 2008 | — |
| −2 | K133527 | Suflex Putty, Suflex Heavy, Suflex Mono, Suflex Light | Osstem Germany GmbH | 2014 | — |
| −1 | K151262 | Hyflex Heavy, Hyflex Mono, Hyflex Light | Osstem Implant Co., Ltd. | 2015 | — |
| 0 (this device) | K170736 | HySil Impression Materials | Osstem Implant Co., Ltd. | 2017 | — |
| +1 | K214086 | Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright… | Genoss Co., Ltd. | 2022 | — |
| +1 | K192941 | HySil Super Fast Impression Materials | Osstem Implant Co., Ltd. | 2020 | — |
| +1 | K181236 | HySil Impression Materials | Osstem Implant Co., Ltd. | 2018 | — |
| +2 | K254152 | Dia-X Sil Light Body | DiaDent Group International | 2026 | — |
| +2 | K254142 | Dia-X Sil Heavy Body | DiaDent Group International | 2026 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K133527 | Suflex Putty, Suflex Heavy, Suflex Mono, Suflex LightSummary page 5…CFR872.3660 Device Classification: Class II Subsequent Product Code: ELW 3. Predicate Device: Primary Predicate K133527, Suflex Impression Meterials to include: (Suflex putty, Suflex Heavy, Suflex Mono, Suflex Light), Osstem Germany GmbH. R… | 2014 |
| * | K151262 | Hyflex Heavy, Hyflex Mono, Hyflex LightSummary page 5…cate K133527, Suflex Impression Meterials to include: (Suflex putty, Suflex Heavy, Suflex Mono, Suflex Light), Osstem Germany GmbH. Reference predicate K151262, Hyflex Impression Materials including to include: (Hyflex Heavy, Hyflex Mono, Hyflex Light), Osstem Implant Co., Ltd. K1… | 2015 |
| * | K152766 | CharmFlexSummary page 5…GmbH. Reference predicate K151262, Hyflex Impression Materials including to include: (Hyflex Heavy, Hyflex Mono, Hyflex Light), Osstem Implant Co., Ltd. K152766, CharmFlex®, Dentkist, Inc 4. Description HySil Impression Materials are addition-curing, elastomeric materials with hydrophi… | 2016 |
What descends from it? (10)
6 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K214086 | Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite… | 2022 | 2 |
| K192941 | HySil Super Fast Impression Materials | 2020 | 2 |
| K181236 | HySil Impression Materials | 2018 | 1 |
| K233954 | Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu | 2024 | 0 |
| K213890 | IMICRYL Impression Materials | 2022 | 0 |
| K201184 | Lascod Impression Materials | 2020 | 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 4 companies; a new generation was cleared every 4.4 years on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K214086 (Genoss Co., Ltd., 2022) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K133527.
How does its category compare?
All ELW devicesELW Material, Impression: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
HySil Putty is to be used as preliminary materials for: ˍ Two-step Putty-wash impression technique ˍ One-step Putty-wash impression technique HySil Heavy is to be used as heavy-bodied materials for: ˍ One-step impression technique (simultaneous technique) using single or dual viscosities ˍ Two-step impression technique using dual viscosities ˍ Functional impressions HySil Mono is to be used as a medium-bodied tray or syringeable impression material for…
Read the full statement (223 words)
HySil Putty is to be used as preliminary materials for:
ˍ Two-step Putty-wash impression technique
ˍ One-step Putty-wash impression technique
HySil Heavy is to be used as heavy-bodied materials for:
ˍ One-step impression technique (simultaneous technique)
using single or dual viscosities
ˍ Two-step impression technique using dual viscosities
ˍ Functional impressions
HySil Mono is to be used as a medium-bodied tray or syringeable impression material for:
ˍ Taking impressions over fixed/removable restorations and implants (i.e., transferring
impression posts and bridge components)
ˍ Functional impressions
ˍ Fabricating crown and bridgework or inlays
ˍ Fabricating full or partial dentures
ˍ Reline impressions
ˍ Use in the simultaneous mixing technique as well as the putty-wash and triple tray
techniques
ˍ Transferring root posts when fabricating posts and cores indirectly
HySil Light is to be used as syringeable impression materials for:
ˍ Two-step putty-wash impression technique
ˍ One-step putty-wash impression technique
ˍ Two-step impression technique using dual viscosities
ˍ Reline impressions
ˍ Fabricating full or partial dentures
HySil Extra Light is to be used as syringeable impression materials for:
ˍ Two-step putty-wash impression technique
ˍ One-step putty-wash impression technique
ˍ Two-step impression technique using dual viscosities
ˍ Reline impressions
ˍ Fabricating full or partial dentures
HySil Bite is used for impression as below.
ˍ Taking occlusal surfaces
ˍ Confirming occlusal surfaces
ˍ Recording after putting the articulator
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170736 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170736: HySil 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/K170736
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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