510(k) · Cleared
ClearedNMF004A
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 Mar 8, 2018 as substantially equivalent to K091388 (GC America, Inc., 2009) and 2 other predicates after a 115-day review. Its family tree reaches back 3 generations to 2004. 2 later devices descend from it.
- Decided
- Mar 8, 2018
- Review
- 115 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K042819 (2004). 6 ancestors in all, the oldest K032921 (2003). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK042819 Tetric EvoceramIvoclar Vivadent, Inc. · 2004
- 2 generations backK091388 GCUC-505GC America, Inc. · 2009
- 1 generation backK123631 MFP-051GC America, Inc. · 2013
- This deviceK173500 NMF004AGC America, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK251946 G aenial Universal Injectable IIGC America, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK250317 EsFlow PLUSSpident Co., Ltd. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K042819 | Tetric Evoceram | Ivoclar Vivadent, Inc. | 2004 | — |
| −2 | K091388 | GCUC-505 | GC America, Inc. | 2009 | — |
| −1 | K123631 | MFP-051 | GC America, Inc. | 2013 | — |
| 0 (this device) | K173500 | NMF004A | GC America, Inc. | 2018 | — |
| +1 | K251946 | G aenial Universal Injectable II | GC America, Inc. | 2025 | — |
| +1 | K250317 | EsFlow PLUS | Spident Co., Ltd. | 2025 | — |
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 |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K091388 | GCUC-505Summary page 4…red Reference GC America Inc. (GCUC-505) G-aenial Universal Flo Primary K091388 7/22/2009 GC America Inc. (MFP-051) G-aenial Sculpt Reference K123631 7/23/201… | 2009 |
| * | K123631 | MFP-051Summary page 4…(GCUC-505) G-aenial Universal Flo Primary K091388 7/22/2009 GC America Inc. (MFP-051) G-aenial Sculpt Reference K123631 7/23/2013 GC America Inc. Kalore (GDLS-200) Reference K082434 11/14/200… | 2013 |
| * | K082434 | GDLS-200Summary page 4…(MFP-051) G-aenial Sculpt Reference K123631 7/23/2013 GC America Inc. Kalore (GDLS-200) Reference K082434 11/14/2008 4. Description of Device: NMF004A is a light cured nano-filled radiopaque composite resin filled in… | 2008 |
What descends from it? (2)
2 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 14 years and passes through 2 companies; a new generation was cleared every 4.6 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K251946 (GC America, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K091388.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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. Liner or base
2. Blocking out undercuts
3. Repair of (in) direct aesthetic restorations, temporary crown & bridge, defect margins when margins are in enamel
4. Sealing hypersensitive areas
5. Fissure sealant
6. Direct restorative for Class I, II, III, IV, V cavities
7. Core build-up
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173500 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173500: NMF004A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173500
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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