510(k) · Cleared
ClearedMD-Flex Heavy Body
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meta Biomed, Inc. · ELW Material, Impression
Cleared on Apr 9, 2014 as substantially equivalent to K040053 (Discus Dental, Inc., 2004) and 1 other predicate after a 100-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Apr 9, 2014
- Review
- 100 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K943574 (1994). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK943574 Capture Impression MaterialDentsply Intl. · 1994
- 2 generations backK021416 Aquasil Ultra Monophase/Heavy/LV Smart Wetting Impression MaterialDentsply Intl. · 2002
- 1 generation backK040053 Precision VPS Impression MaterialDiscus Dental, Inc. · 2004
- This deviceK134008 MD-Flex Heavy BodyMeta Biomed, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K943574 | Capture Impression Material | Dentsply Intl. | 1994 | — |
| −2 | K021416 | Aquasil Ultra Monophase/Heavy/LV Smart Wetting Impression Material | Dentsply Intl. | 2002 | — |
| −1 | K040053 | Precision VPS Impression Material | Discus Dental, Inc. | 2004 | — |
| 0 (this device) | K134008 | MD-Flex Heavy Body | Meta Biomed, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2010 | 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? (2)
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 |
|---|---|---|---|
| * | K040053 | Precision VPS Impression MaterialSummary page 1…: Manufacturer Discus Dental, Inc. Device Precision VPS Impression Material 510(k) Number K040053 Manufacturer Heraeus Kuizer, LLC Device Flexitime Xtreme 2 Heavy Tray… | 2004 |
| * | K101617 | Flexitime Xtreme 2 Heavy Tray Cartridge Refill, Fexitime Xtreme 2 Light Tray Cartridge…Summary page 1…40053 Manufacturer Heraeus Kuizer, LLC Device Flexitime Xtreme 2 Heavy Tray 510(k) Number K101617 4-2 7. Device Description: MD-fle… | 2010 |
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 20 years and passes through 3 companies; a new generation was cleared every 7.7 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 3 other devices also cite its predicate K040053.
How does its category compare?
All ELW devicesELW Material, Impression: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
MVD-flex Heavy Body is used to record the shape of the patients teeth and
alveolar ridges.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K134008 · printed Nov 6, 2026
Cite this page
510(k) Report. “K134008: MD-Flex Heavy Body.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K134008
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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