510(k) · Cleared
ClearedMFP-051
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GC America, Inc. · EBF Material, Tooth Shade, Resin
Cleared on Jul 23, 2013 as substantially equivalent to K082434 (GC America, Inc., 2008) and 3 other predicates after a 242-day review. Its family tree reaches back 2 generations to 2004. 39 later devices descend from it.
- Decided
- Jul 23, 2013
- Review
- 242 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K042819 (2004). 5 ancestors in all, the oldest K032921 (2003). 39 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK042819 Tetric EvoceramIvoclar Vivadent, Inc. · 2004
- 1 generation backK091388 GCUC-505GC America, Inc. · 2009
- This deviceK123631 MFP-051GC America, Inc. · 2013
- Descendant · cites it directly · 32 of its ownK133824 CerasmartGC America, Inc. · 2014
- Descendant · 2 generations on · 26 of its ownK160425 CAD/CAMouflage Milling BockPrismatik Dentalcraft, Inc. · 2016
- Descendant · 3 generations on · 25 of its ownK162537 CAD/CAMouflage Milling BlockPrismatik Dentalcraft, Inc. · 2016
- Descendant · 4 generations on · 24 of its ownK201668 VarseoSmile Crown plusBego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG · 2020
- Descendant · 5 generations on · 13 of its ownK202846 Tera HarzGraphy, Inc. · 2021
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K133824CerasmartGC America, Inc. · 2014 · cites it directly32descendants
- K160425CAD/CAMouflage Milling BockPrismatik Dentalcraft, Inc. · 2016 · 2 generations on26descendants
- K162537CAD/CAMouflage Milling BlockPrismatik Dentalcraft, Inc. · 2016 · 3 generations on25descendants
- K201668VarseoSmile Crown plusBego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG · 2020 · 4 generations on24descendants
- K202846Tera HarzGraphy, Inc. · 2021 · 5 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K042819 | Tetric Evoceram | Ivoclar Vivadent, Inc. | 2004 | — |
| −1 | K091388 | GCUC-505 | GC America, Inc. | 2009 | — |
| 0 (this device) | K123631 | MFP-051 | GC America, Inc. | 2013 | — |
| +1 | K133824 | Cerasmart | GC America, Inc. | 2014 | — |
| +2 | K160425 | CAD/CAMouflage Milling Bock | Prismatik Dentalcraft, Inc. | 2016 | — |
| +3 | K162537 | CAD/CAMouflage Milling Block | Prismatik Dentalcraft, Inc. | 2016 | — |
| +4 | K201668 | VarseoSmile Crown plus | Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG | 2020 | — |
| +5 | K202846 | Tera Harz | Graphy, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 7 | 0 |
| 2025 | 5 | 0 |
| 2026 | 6 | 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? (4)
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 |
|---|---|---|---|
| * | K082434 | GDLS-200Summary page 1…Company Device 51 0(k) No. Date Cleared GC America Inc. GC KALORE (GDLS-200) K082434 I11/14/2008 GC AMERICA, INC ________________(GCUC-505)… | 2008 |
| * | K091388 | GCUC-505Summary page 1…4 I11/14/2008 GC AMERICA, INC ________________(GCUC-505) G-aenial Universal Flo K091388 ____… | 2009 |
| * | K032921 | PremiseSummary page 1…____ KERR CORPORATION PREMISE K032921 -11/13/2003 Ivoclar Vivadent. Inc. Tetric Evoceram K0-42819 11/09/2004… | 2003 |
| * | K042819 | Tetric Evoceram | 2004 |
What descends from it? (39)
See all 395 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?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 4.7 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K133824 (GC America, Inc., 2014) has gone furthest, with 32 descendants of its own.
- 4 other devices also cite its predicate K082434.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
1. Direct restorative for class I, HI, all IV,V cavities.
2. Direct restorative for wedge-shaped defects and root surface cavities.
3. Direct restorative for veneers and diastema closure.
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/K123631 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123631: MFP-051.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123631
Report an extraction error
Are you the manufacturer?
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