510(k) · Cleared
ClearedBright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genoss Co., Ltd. · ELW Material, Impression
Cleared on Dec 15, 2022 as substantially equivalent to K170736 (Osstem Implant Co., Ltd., 2017) after a 353-day review. Its family tree reaches back 7 generations to 1994. 2 later devices descend from it.
- Decided
- Dec 15, 2022
- Review
- 353 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. 2 later devices descend from it, 2 citing it directly.
- 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 deviceK214086 Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy…Genoss Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK254152 Dia-X Sil Light BodyDiaDent Group International · 2026
- Descendant · cites it directly · 0 of its ownK254142 Dia-X Sil Heavy BodyDiaDent Group International · 2026
Most influential descendants
Showing 2 of 2 · See allView 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) | K214086 | Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright… | Genoss Co., Ltd. | 2022 | — |
| +1 | K254152 | Dia-X Sil Light Body | DiaDent Group International | 2026 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K170736 | HySil Impression MaterialsSummary page 4…: Impression Material Classification name: Dental Impression Material Common Name: Material, Impression 3. Predicate Device K170736 Hysil Impression Materials 4. Description Bright Impress impression material is a fast-set of additio… | 2017 |
What descends from it? (2)
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?
- The line of descent spans 28 years and passes through 5 companies; a new generation was cleared every 4.4 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K254152 (DiaDent Group International, 2026) has gone furthest, with 0 descendants of its own.
- 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. 2022, 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?
Impression of inlay, onlay crown, and bridge preparation
- Crown, bridge impression
- Inlay and onlay impression
- Functional impression
- Denture impression
- Study model impression
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K214086 · printed Nov 6, 2026
Cite this page
510(k) Report. “K214086: Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K214086
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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