510(k) · Cleared
Cleared3M Dent II System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Company · EBF Material, Tooth Shade, Resin
Cleared on Aug 9, 1998 after a 90-day review. The FDA summary names its predicate without a number. 11 later devices descend from it.
- Decided
- Aug 9, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 2 citing it directly.
- This deviceK981647 3M Dent II System3M Company · 1998
- 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 · cites it directly · 1 of its ownK151094 Mosaic Universal CompositeUltradent Products, Inc. · 2015
- Descendant · 4 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- 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
- K151094Mosaic Universal CompositeUltradent Products, Inc. · 2015 · cites it directly1descendant
- K253513MultiMatch Flow Chameleon AntiMicrobial CompositePremier Dental Products Company · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981647 | 3M Dent II System | 3M Company | 1998 | — |
| +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 | — |
| +1 | K151094 | Mosaic Universal Composite | Ultradent Products, Inc. | 2015 | — |
| +4 | K253513 | MultiMatch Flow Chameleon AntiMicrobial Composite | Premier Dental Products Company | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 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? (5)
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 |
|---|---|---|---|
| * | — | 3M™ Z100™ Restorative Named without a submission number | |
| * | — | Prisma TPH™ Spectrum Named without a submission number | |
| * | — | XRV™ Herculite® Named without a submission number | |
| * | — | Alert™ Named without a submission number | |
| * | — | SureFil™ Named without a submission number |
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?
- Of its descendants, K120453 (3M Espe Dental Products, 2012) has gone furthest, with 8 descendants of its own.
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?
Indications:
* Direct anterior restorations including:
- Class III, IV, V, and VI
- Veneers
- Incisal edge repair
* Direct posterior restorations including:
- Class I or II
- Sandwich technique with glass ionomer resin material
- Cusp Buildups
* Core Buildups
* Splinting
* Indirect anterior and posterior restoration including:
- Inlays
- Onlays
- Veneers
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/K981647 · printed Nov 5, 2026
Cite this page
510(k) Report. “K981647: 3M Dent II System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981647
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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