510(k) · Cleared
ClearedCharmFlex
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentkist, Inc. · ELW Material, Impression
Cleared on Mar 8, 2016 as substantially equivalent to K103164 (Vericom Co., Ltd., 2010) after a 166-day review. Its family tree reaches back 4 generations to 1994. 12 later devices descend from it.
- Decided
- Mar 8, 2016
- Review
- 166 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K943574 (1994). 5 ancestors in all. 12 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK943574 Capture Impression MaterialDentsply Intl. · 1994
- 3 generations backK970433 Aquasil Rigid Smart Wetting Impression MaterialDentsply Intl. · 1997
- 2 generations backK021413 Aquasil Ultra Rigid Smart Wetting Impression MaterialDentsply Intl. · 2002
- 1 generation backK103164 Vonflex Heavy, Vinflex LightVericom Co., Ltd. · 2010
- This deviceK152766 CharmFlexDentkist, Inc. · 2016
- 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 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · 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 |
|---|---|---|---|---|---|
| −4 | K943574 | Capture Impression Material | Dentsply Intl. | 1994 | — |
| −3 | K970433 | Aquasil Rigid Smart Wetting Impression Material | Dentsply Intl. | 1997 | — |
| −2 | K021413 | Aquasil Ultra Rigid Smart Wetting Impression Material | Dentsply Intl. | 2002 | — |
| −1 | K103164 | Vonflex Heavy, Vinflex Light | Vericom Co., Ltd. | 2010 | — |
| 0 (this device) | K152766 | CharmFlex | Dentkist, Inc. | 2016 | — |
| +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 |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K103164 | Vonflex Heavy, Vinflex LightSummary page 4…- CharmFlex® Bite Clear - CharmFlex® Bite Fast 3. The legally marketed device to w hich w e are claiming equivalence Primary Predicate: K103164 VonflexT M Heavy/Vonf lexTM Light Reference Predicates: K091267 VonflexTM Putty K140966 VonflexTM Bite Manuf acutred by… | 2010 |
| † | K091267 | Vonflex Putty | 2009 |
| † | K140966 | Vonflex S Bite | 2014 |
What descends from it? (12)
See all 122 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 22 years and passes through 3 companies; a new generation was cleared every 5.3 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K170736 (Osstem Implant Co., Ltd., 2017) has gone furthest, with 10 descendants of its own.
How does its category compare?
All ELW devicesELW Material, Impression: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 material in a dual phase impression technique
- Precise duplication of models
- Capturing multiple unit impressions
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/K152766 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152766: CharmFlex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152766
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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