510(k) · Cleared
ClearedFlextime Fast & Scan Putty, Flextime Fast & Scan Light Flow, Flextime Fast & Scan Medium Flow
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 Dec 21, 2010 after an 88-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Dec 21, 2010
- Review
- 88 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK102770 Flextime Fast & Scan Putty, Flextime Fast & Scan Light Flow…Heraeus Kulzer, LLC · 2010
- Descendant · cites it directly · 1 of its ownK113574 Flexitime Monophase Pro ScanHeraeus Kulzer, LLC · 2012
- Descendant · 2 generations on · 0 of its ownK130647 Xantasil Dynamix Fast Set Cartridge -2 X 380ML; Xantasil Fast Set…Heraeus Kulzer, LLC · 2013
- Descendant · cites it directly · 0 of its ownK120914 Flexitime Fast & Scan Light FlowHeraeus Kulzer, LLC · 2012
Most influential descendants
Showing 3 of 3 · See all- K113574Flexitime Monophase Pro ScanHeraeus Kulzer, LLC · 2012 · cites it directly1descendant
- K130647Xantasil Dynamix Fast Set Cartridge -2 X 380ML; Xantasil Fast Set Cartridge -6 X 50MLHeraeus Kulzer, LLC · 2013 · 2 generations on0descendants
- K120914Flexitime Fast & Scan Light FlowHeraeus Kulzer, LLC · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K102770 | Flextime Fast & Scan Putty, Flextime Fast & Scan Light Flow, Flextime Fast &… | Heraeus Kulzer, LLC | 2010 | — |
| +1 | K113574 | Flexitime Monophase Pro Scan | Heraeus Kulzer, LLC | 2012 | — |
| +2 | K130647 | Xantasil Dynamix Fast Set Cartridge -2 X 380ML; Xantasil Fast Set Cartridge -6… | Heraeus Kulzer, LLC | 2013 | — |
| +1 | K120914 | Flexitime Fast & Scan Light Flow | Heraeus Kulzer, LLC | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 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? (3)
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 |
|---|---|---|---|
| * | — | Flexitime Dynamix Putty Named without a submission number | |
| * | — | Flexitime Light Flow Named without a submission number | |
| * | — | Flexitime Medium Flow Named without a submission number |
What descends from it? (3)
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?
- Of its descendants, K113574 (Heraeus Kulzer, LLC, 2012) has gone furthest, with 1 descendant 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. 2010, 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?
Flexitime Fast & Scan is an addition-cross-linking polyvinyl siloxane impression material for all inlay, crown and bridges, edentulous and partial impression.
The Flexitime Fast & Scan range products are prepared without requiring additional surface treatment for optical scanning in dental scanners designed for scanning impression materials, such as the 3 Shape 0700 laser scanners.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102770 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102770: Flextime Fast & Scan Putty, Flextime Fast & Scan Light Flow, Flextime Fast & Scan Medium Flow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102770
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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