510(k) · Cleared
ClearedHyflex Heavy, Hyflex Mono, Hyflex Light
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 Sep 21, 2015 as substantially equivalent to K133527 (Osstem Germany GmbH, 2014) after a 131-day review. Its family tree reaches back 5 generations to 1994. 11 later devices descend from it.
- Decided
- Sep 21, 2015
- Review
- 131 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K943574 (1994). 9 ancestors in all. 11 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK943574 Capture Impression MaterialDentsply Intl. · 1994
- 4 generations backK973782 Aquasil XLV Smart Wetting Impression MaterialDentsply Intl. · 1997
- 3 generations backK021410 Aquasil Ultra XLV Smart Wetting Impression MaterialDentsply Intl. · 2002
- 2 generations backK082560 Panasil Impression Materials, Including Putty, Binetics, Tray…Kettenbach GmbH & Co. KG · 2008
- 1 generation backK133527 Suflex Putty, Suflex Heavy, Suflex Mono, Suflex LightOsstem Germany GmbH · 2014
- This deviceK151262 Hyflex Heavy, Hyflex Mono, Hyflex LightOsstem Implant Co., Ltd. · 2015
- Descendant · cites it directly · 10 of its ownK170736 HySil Impression MaterialsOsstem Implant Co., Ltd. · 2017
- Descendant · 2 generations on · 2 of its ownK214086 Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy…Genoss Co., Ltd. · 2022
- Descendant · 2 generations on · 2 of its ownK192941 HySil Super Fast Impression MaterialsOsstem Implant Co., Ltd. · 2020
- Descendant · 2 generations on · 1 of its ownK181236 HySil Impression MaterialsOsstem Implant Co., Ltd. · 2018
- Descendant · 3 generations on · 0 of its ownK254152 Dia-X Sil Light BodyDiaDent Group International · 2026
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K170736HySil Impression MaterialsOsstem Implant Co., Ltd. · 2017 · cites it directly10descendants
- K214086Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite…Genoss Co., Ltd. · 2022 · 2 generations on2descendants
- K192941HySil Super Fast Impression MaterialsOsstem Implant Co., Ltd. · 2020 · 2 generations on2descendants
- K181236HySil Impression MaterialsOsstem Implant Co., Ltd. · 2018 · 2 generations on1descendant
- K254152Dia-X Sil Light BodyDiaDent Group International · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K943574 | Capture Impression Material | Dentsply Intl. | 1994 | — |
| −4 | K973782 | Aquasil XLV Smart Wetting Impression Material | Dentsply Intl. | 1997 | — |
| −3 | K021410 | Aquasil Ultra XLV Smart Wetting Impression Material | Dentsply Intl. | 2002 | — |
| −2 | K082560 | Panasil Impression Materials, Including Putty, Binetics, Tray, Monophase and… | Kettenbach GmbH & Co. KG | 2008 | — |
| −1 | K133527 | Suflex Putty, Suflex Heavy, Suflex Mono, Suflex Light | Osstem Germany GmbH | 2014 | — |
| 0 (this device) | K151262 | Hyflex Heavy, Hyflex Mono, Hyflex Light | Osstem Implant Co., Ltd. | 2015 | — |
| +1 | K170736 | HySil Impression Materials | Osstem Implant Co., Ltd. | 2017 | — |
| +2 | K214086 | Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright… | Genoss Co., Ltd. | 2022 | — |
| +2 | K192941 | HySil Super Fast Impression Materials | Osstem Implant Co., Ltd. | 2020 | — |
| +2 | K181236 | HySil Impression Materials | Osstem Implant Co., Ltd. | 2018 | — |
| +3 | K254152 | Dia-X Sil Light 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 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K133527 | Suflex Putty, Suflex Heavy, Suflex Mono, Suflex LightSummary page 4…ELW 3. Predicate Device: Trade Name: Suflex Impression Meterials to include:(Suflex putty, Suflex Heavy, Suflex Mono, Suflex Light) K133527 1/4 OSSTEM Implant Co., Ltd.… | 2014 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170736 | HySil Impression Materials | 2017 | 10 |
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 21 years and passes through 4 companies; a new generation was cleared every 4.4 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K170736 (Osstem Implant Co., Ltd., 2017) has gone furthest, with 10 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. 2015, 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?
Hyflex Heavy and Mono are to be used as heavy-bodied materials for; - One step impression technique (simultaneous technique) using single or dual viscosities. - Two step impression technique using dual viscosities. - Functional impressions. Hyflex Mono is to be used as a medium-bodied tray or syringeable impression material for; - Taking impression over fixed/removable restorations and implants (i.e., transferring impression posts and bridge components)…
Read the full statement (152 words)
Hyflex Heavy and Mono are to be used as heavy-bodied materials for;
- One step impression technique (simultaneous technique) using single or dual viscosities.
- Two step impression technique using dual viscosities.
- Functional impressions.
Hyflex Mono is to be used as a medium-bodied tray or syringeable impression material for;
- Taking impression over fixed/removable restorations and implants (i.e., transferring impression posts and bridge components)
- Functional impressions.
- Fabricating crown and bridgework or inlays.
- Fabricating full or partial dentures.
- Reline impressions.
- Use in the simultaneous mixing technique as well as the putty-wash and triple tray techniques.
- Transferring root posts when fabricating posts and cores indirectly.
Hyflex Light is to be used as syringeable impression materials for;
- Two step putty-wash impression technique.
- One step putty-wash impression technique.
- One step impression technique using a foil(plastic putty spacer).
- Reline impressions.
- Fabricating full or partial dentures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151262 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151262: Hyflex Heavy, Hyflex Mono, Hyflex Light.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151262
Report an extraction error
Are you the manufacturer?
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