510(k) · Cleared
ClearedAdaptable Composite Resin Restorative Material
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply International, Inc. · EBF Material, Tooth Shade, Resin
Cleared on Apr 14, 2009 as substantially equivalent to K981965 (Dentsply Intl., 1998) after a 111-day review. Its family tree reaches back 2 generations to 1994. 9 later devices descend from it.
- Decided
- Apr 14, 2009
- Review
- 111 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K940459 (1994). 3 ancestors in all. 9 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK940459 Multipurpose Resin Cement with Fluoride (MRCF)Dentsply Intl. · 1994
- 1 generation backK981965 Flowable CompositeDentsply Intl. · 1998
- This deviceK083841 Adaptable Composite Resin Restorative MaterialDentsply International, Inc. · 2009
- Descendant · cites it directly · 8 of its ownK120453 Filtek Bulk Fill Flowable Restorative3M Espe Dental Products · 2012
- Descendant · 2 generations on · 2 of its ownK182714 Novidia Bulk Fill Flow CompositeNobio, Ltd. · 2019
- Descendant · 3 generations on · 1 of its ownK201010 Infinix Universal Composite, Infinix Flowable Composite, Infinix…Nobio, Ltd. · 2020
- Descendant · 4 generations on · 0 of its ownK253513 MultiMatch Flow Chameleon AntiMicrobial CompositePremier Dental Products Company · 2025
- Descendant · 2 generations on · 0 of its ownK242713 Any-Com BulkMediclus Co., Ltd. · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K120453Filtek Bulk Fill Flowable Restorative3M Espe Dental Products · 2012 · cites it directly8descendants
- K182714Novidia Bulk Fill Flow CompositeNobio, Ltd. · 2019 · 2 generations on2descendants
- K201010Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow CompositeNobio, Ltd. · 2020 · 3 generations on1descendant
- K253513MultiMatch Flow Chameleon AntiMicrobial CompositePremier Dental Products Company · 2025 · 4 generations on0descendants
- K242713Any-Com BulkMediclus Co., Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K940459 | Multipurpose Resin Cement with Fluoride (MRCF) | Dentsply Intl. | 1994 | — |
| −1 | K981965 | Flowable Composite | Dentsply Intl. | 1998 | — |
| 0 (this device) | K083841 | Adaptable Composite Resin Restorative Material | Dentsply International, Inc. | 2009 | — |
| +1 | K120453 | Filtek Bulk Fill Flowable Restorative | 3M Espe Dental Products | 2012 | — |
| +2 | K182714 | Novidia Bulk Fill Flow Composite | Nobio, Ltd. | 2019 | — |
| +3 | K201010 | Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill… | Nobio, Ltd. | 2020 | — |
| +4 | K253513 | MultiMatch Flow Chameleon AntiMicrobial Composite | Premier Dental Products Company | 2025 | — |
| +2 | K242713 | Any-Com Bulk | Mediclus Co., Ltd. | 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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 2 | 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 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K041404 | FDA’s K041404 is Clearblue Easy Easy Read Pregnancy Test Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2004 |
| * | K981965 | Flowable CompositeSummary page 1…Device I510(k) Number Date Cleared DENTSPLY Quixx Postero Rsoaie K41404/01/2004 International rFlowable Cornposite K981965 07/10/1998 4. Description of Device: The Adaptable Composite Resin Restorative Material is a one-component, flu… | 1998 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120453 | Filtek Bulk Fill Flowable Restorative | 2012 | 8 |
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 15 years and passes through 2 companies; a new generation was cleared every 10.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K120453 (3M Espe Dental Products, 2012) has gone furthest, with 8 descendants of its own.
- 1 other device also cites its predicate K981965.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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?
Adaptable Composite Resin Restorative Material is indicated for the following procedures: 1. Indications with tooth/restorative interface * Class III and V restorations * Conservative Class I restorations * Small Class IV repairs * Tunnel Preparations * Filling of defects and undercuts in crown, inlay and onlay preparations * Blockouts * As a liner under direct restorative materials and under inlays restorations - Class II box liner * As a base or liner…
Read the full statement (145 words)
Adaptable Composite Resin Restorative Material is indicated for the following procedures:
1. Indications with tooth/restorative interface
* Class III and V restorations
* Conservative Class I restorations
* Small Class IV repairs
* Tunnel Preparations
* Filling of defects and undercuts in crown, inlay and onlay preparations
* Blockouts
* As a liner under direct restorative materials and under inlays restorations - Class II box liner
* As a base or liner for cavity Class I and II restorations
* Repair of small enamel defects
* Covering incisal edge stains
* Pit and fissure Sealant
2. Indications including tooth/indirect restorative materials
* Cementing porcelain veneers, crowns, inlays/onlays
* Intraoral porcelain repair
3. Amalgam margin repair
4. Provisional or Indirect Laboratory Indications:
* Improving margins of acrylic temporaries
* Provisional occlusal changes
* Refacing acrylic temporaries
* Margin correction/adjustment of composite crowns for indirect laboratory use
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083841 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083841: Adaptable Composite Resin Restorative Material.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083841
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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