510(k) · Cleared
ClearedFlexitime Monophase Pro Scan
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heraeus Kulzer, LLC · ELW Material, Impression
Cleared on Jul 13, 2012 as substantially equivalent to K102770 (Heraeus Kulzer, LLC, 2010) and 1 other predicate after a 224-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.
- Decided
- Jul 13, 2012
- Review
- 224 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K000629 (2000). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K130647Xantasil Dynamix Fast Set Cartridge -2 X 380ML; Xantasil Fast Set Cartridge -6 X 50MLHeraeus Kulzer, LLC · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000629 | Flextime | Heraeus Kulzer, Inc. | 2000 | — |
| 0 (this device) | K113574 | Flexitime Monophase Pro Scan | Heraeus Kulzer, LLC | 2012 | — |
| +1 | K130647 | Xantasil Dynamix Fast Set Cartridge -2 X 380ML; Xantasil Fast Set Cartridge -6… | Heraeus Kulzer, LLC | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 |
|---|---|---|---|
| * | K102770 | Flextime Fast & Scan Putty, Flextime Fast & Scan Light Flow, Flextime Fast & Scan Medium…Summary page 1…pared: November 2, 2011 {Revised February 20, 2012) . Legally Market Devices to which Substantial Equivalence is claimed: Heraeus Kulzer, GmBH - Flexitime Fast & Scan K102770 Heraeus Kulzer, GmBH - Flexithme Monophase KOG0629 Device Identification Trade /Proprietary Name: Flextime Monaphase I'ro Scan… | 2010 |
| * | K000629 | FlextimeSummary page 2…6. Technological Characteristics The physical proper ties of Flexitimne Monlophase Pro Scan like Flexi time Fast and Scan (1(102770) and Flexiime Monophase (K000629) are in) compliance with ISO 4823. Bothl Fl exit Ine Io no phaIse Pro Scan and Flexitime Fast and Scan (K 102770) are p repa… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130647 | Xantasil Dynamix Fast Set Cartridge -2 X 380ML; Xantasil Fast Set Cartridge -6 X 50ML | 2013 | 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?
How does its category compare?
All ELW devicesELW Material, Impression: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
It is used to get an exact negative copy of the patient's dental situation and can be used for optical scanning in dental scanners designed for scanning impression material.
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/K113574 · printed Nov 5, 2026
Cite this page
510(k) Report. “K113574: Flexitime Monophase Pro Scan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K113574
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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