510(k) · Cleared
ClearedFlowable Composite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Intl. · EMA Cement, Dental
Cleared on Jul 10, 1998 as substantially equivalent to K940459 (Dentsply Intl., 1994) and 1 other predicate after a 36-day review. Its family tree reaches back 1 generation to 1994. 11 later devices descend from it.
- Decided
- Jul 10, 1998
- Review
- 36 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K940459 (1994). 2 ancestors in all. 11 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK940459 Multipurpose Resin Cement with Fluoride (MRCF)Dentsply Intl. · 1994
- This deviceK981965 Flowable CompositeDentsply Intl. · 1998
- Descendant · cites it directly · 9 of its ownK083841 Adaptable Composite Resin Restorative MaterialDentsply International, Inc. · 2009
- Descendant · 2 generations on · 8 of its ownK120453 Filtek Bulk Fill Flowable Restorative3M Espe Dental Products · 2012
- Descendant · 3 generations on · 2 of its ownK182714 Novidia Bulk Fill Flow CompositeNobio, Ltd. · 2019
- Descendant · 4 generations on · 1 of its ownK201010 Infinix Universal Composite, Infinix Flowable Composite, Infinix…Nobio, Ltd. · 2020
- Descendant · 5 generations on · 0 of its ownK253513 MultiMatch Flow Chameleon AntiMicrobial CompositePremier Dental Products Company · 2025
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K083841Adaptable Composite Resin Restorative MaterialDentsply International, Inc. · 2009 · cites it directly9descendants
- K120453Filtek Bulk Fill Flowable Restorative3M Espe Dental Products · 2012 · 2 generations on8descendants
- K182714Novidia Bulk Fill Flow CompositeNobio, Ltd. · 2019 · 3 generations on2descendants
- K201010Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow CompositeNobio, Ltd. · 2020 · 4 generations on1descendant
- K253513MultiMatch Flow Chameleon AntiMicrobial CompositePremier Dental Products Company · 2025 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K940459 | Multipurpose Resin Cement with Fluoride (MRCF) | Dentsply Intl. | 1994 | — |
| 0 (this device) | K981965 | Flowable Composite | Dentsply Intl. | 1998 | — |
| +1 | K083841 | Adaptable Composite Resin Restorative Material | Dentsply International, Inc. | 2009 | — |
| +2 | K120453 | Filtek Bulk Fill Flowable Restorative | 3M Espe Dental Products | 2012 | — |
| +3 | K182714 | Novidia Bulk Fill Flow Composite | Nobio, Ltd. | 2019 | — |
| +4 | K201010 | Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill… | Nobio, Ltd. | 2020 | — |
| +5 | K253513 | MultiMatch Flow Chameleon AntiMicrobial Composite | Premier Dental Products Company | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 EMA? 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 EMA device
- #1 K254109 G-Cem Universalscore 15.0 · 13 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 |
|---|---|---|---|
| * | K940459 | Multipurpose Resin Cement with Fluoride (MRCF)Summary page 1…E COMPOSITE COMMON OR USUAL NAME: Dental restorative material CLASSIFICATION NAME: Tooth shade resin material 872.3690 PREDICATE DEVICE: Enforce® with Fluoride Cement K940459 Aeliteflo K955292 DEVICE DESCRIPTION: FLOWABLE COMPOSITE is a one-component, moderately filled, visible light cured dental compo… | 1994 |
| * | K955292 | AelitefloSummary page 1…N OR USUAL NAME: Dental restorative material CLASSIFICATION NAME: Tooth shade resin material 872.3690 PREDICATE DEVICE: Enforce® with Fluoride Cement K940459 Aeliteflo K955292 DEVICE DESCRIPTION: FLOWABLE COMPOSITE is a one-component, moderately filled, visible light cured dental composite restorative m… | 1995 |
What descends from it? (11)
See all 112 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?
How does its category compare?
All EMA devicesEMA Cement, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EMA
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EMA
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EMA
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EMA
9in 2025
MAUDE reports naming product code EMA, 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 | 6 | 48 | 0 | 33 |
| 2008 | 13 | 71 | 2 | 50 |
| 2009 | 10 | 86 | 1 | 90 |
| 2010 | 14 | 86 | 1 | 106 |
| 2011 | 8 | 79 | 5 | 224 |
| 2012 | 10 | 128 | 0 | 249 |
| 2013 | 12 | 178 | 0 | 385 |
| 2014 | 4 | 174 | 0 | 207 |
| 2015 | 9 | 134 | 0 | 85 |
| 2016 | 10 | 182 | 0 | 16 |
| 2017 | 3 | 141 | 0 | 13 |
| 2018 | 3 | 237 | 0 | 4 |
| 2019 | 7 | 127 | 0 | 12 |
| 2020 | 8 | 164 | 0 | 5 |
| 2021 | 4 | 184 | 0 | 8 |
| 2022 | 7 | 245 | 0 | 3 |
| 2023 | 2 | — | 1 | 6 |
| 2024 | 3 | 59 | 0 | 5 |
| 2025 | 10 | 106 | 0 | 9 |
| 2026 | 7 | 150 | 0 | — |
What is it indicated for?
Filling of defects and undercuts in crowns, inlays and onlays;
Liner under direct restorative materials and under inlay restorations—Class II box liner;
Tunnel preparations;
Pit and fissure sealants;
Amalgam margin repair; Improving margins of acrylic temporaries;
Small class IV repairs;
Intraoral porcelain repair;
Cementing porcelain veneers, crowns, inlays/onlays;
Refacing acrylic temporaries;
Blockouts;
Covering incisal edge stains;
Repair of small enamel defects;
Provisional occlusal changes;
Class III, V restorations;
Conservative Class I restorations;
Margin correction/adjustment of composite crowns for indirect laboratory use
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/K981965 · printed Nov 3, 2026
Cite this page
510(k) Report. “K981965: Flowable Composite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K981965
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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