510(k) · Cleared
Recalled · 2010Revolution Formula 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sybron Dental Specialties, Inc. · EBF Material, Tooth Shade, Resin
Cleared on Jan 16, 2002 after a 72-day review. The FDA summary names its predicate without a number. 11 later devices descend from it. It has been recalled once.
- Decided
- Jan 16, 2002
- Review
- 72 days
- Class
- Class II
- Product code
- EBF
- Recalls
- 1
- Predicates
- 0
11 later devices descend from it, 3 citing it directly.
- This deviceK013647 Revolution Formula 2Sybron Dental Specialties, Inc. · 2002
- 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 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
- 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 |
|---|---|---|---|---|---|
| 0 (this device) | K013647 | Revolution Formula 2 | Sybron Dental Specialties, Inc. | 2002 | — |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 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? (1)
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 |
|---|---|---|---|
| * | — | Kerr Corporation, Prodigy 3 Named without a submission number |
What descends from it? (11)
See all 113 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 15, 2010 | Not classified | Z-0716-2011 | Other | Patterson Dental is conducting a recall because they have been advised by the manufacturer of Revolution Formula 2 (Kerr Corporation) that some syringes and tips marked with the brand name are not manufactured and distributed by Kerr and… |
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?
The intended use of Revolution Formula 2 is for the restoration of Class III, Class IV, and Class V cavities, repair of enamel defects, repair of porcelain restorations, minor occlusal build-ups in non= stress bearing areas, pit and fissure sealant, cement for ceramic/composite veneers, incisal abrasions, and core build-ups.
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/K013647 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013647: Revolution Formula 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013647
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026