510(k) · Cleared
ClearedLatit Flow
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ab Ardent · EBF Material, Tooth Shade, Resin
Cleared on Jul 20, 2004 after a 148-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jul 20, 2004
- Review
- 148 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EBF? 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 EBF device
- #1 K202846 Tera Harzscore 18.5 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EBF
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBF
43in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBF
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBF
1in 2025
MAUDE reports naming product code EBF, 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 | 19 | 49 | 1 | 6 |
| 2008 | 14 | 79 | 42 | 10 |
| 2009 | 20 | 84 | 1 | 8 |
| 2010 | 19 | 75 | 6 | 31 |
| 2011 | 19 | 81 | 7 | 31 |
| 2012 | 11 | 86 | 0 | 62 |
| 2013 | 13 | 153 | 0 | 246 |
| 2014 | 10 | 112 | 0 | 195 |
| 2015 | 17 | 123 | 0 | 119 |
| 2016 | 20 | 205 | 0 | 143 |
| 2017 | 15 | 108 | 4 | 42 |
| 2018 | 15 | 115 | 0 | 8 |
| 2019 | 17 | 159 | 2 | 11 |
| 2020 | 15 | 190 | 1 | 2 |
| 2021 | 13 | 178 | 0 | 2 |
| 2022 | 17 | 63 | 0 | 2 |
| 2023 | 9 | 87 | 0 | 8 |
| 2024 | 18 | 120 | 0 | 5 |
| 2025 | 15 | 43 | 0 | 1 |
| 2026 | 16 | 59 | 2 | — |
What is it indicated for?
LATIT FLOW is to be used as a filling material for restoring function to teeth that have lost portions due to caries: Direct, fixed restorations, placed by the dentist after removal of carious tissue. Anterior restorations, Class lII, IV Class V restorations, cervical caries, root erosion, wedge shaped defects. Small posterior restorations, Class I, Mini cavities, minimal invasion dentistry Veneering of discolored anterior teeth Splinting of mobile…
Read the full statement (134 words)
LATIT FLOW is to be used as a filling material for restoring function to teeth that have lost portions due to caries:
Direct, fixed restorations, placed by the dentist after removal of carious tissue.
Anterior restorations, Class lII, IV
Class V restorations, cervical caries, root erosion, wedge shaped defects.
Small posterior restorations, Class I,
Mini cavities, minimal invasion dentistry
Veneering of discolored anterior teeth
Splinting of mobile teeth.
Preventive restorations in molars and premolars.
Repair of composite and ceramic veneers.
Luting of porcelain and composite veneers
As first layer of Class I or II restorations
Contra indications:
The placement of LATIT FLOW is contraindicated
If a dry working field cannot be established or if the stipulated technique cannot be applied.
If the patient is known to be allergic to the components of LATIT FLOW.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K040465 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040465: Latit Flow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040465
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026