510(k) · Cleared
ClearedBuild-IT Total Core
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pentron Clinical · EBF Material, Tooth Shade, Resin
Cleared on Jan 5, 2011 as substantially equivalent to K000211 (Jeneric/Pentron, Inc., 2000) and 1 other predicate after a 107-day review. Its family tree reaches back 2 generations to 2004. 3 later devices descend from it.
- Decided
- Jan 5, 2011
- Review
- 107 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K041474 (2004). 3 ancestors in all, the oldest K000211 (2000). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK041474 MaxcemSybron Dental Specialties, Inc. · 2004
- 1 generation backK060698 Cement-IT All Purpose, Model N97Pentron Clinical Technologies · 2006 · Recalled
- This deviceK102703 Build-IT Total CorePentron Clinical · 2011
- Descendant · cites it directly · 1 of its ownK153127 everX PosteriorGC America, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK231263 Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NTPrevest Denpro Limited · 2024
- Descendant · 2 generations on · 0 of its ownK192260 everX FlowGC America, Inc. · 2019
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K041474 | Maxcem | Sybron Dental Specialties, Inc. | 2004 | — |
| −1 | K060698 | Cement-IT All Purpose, Model N97 | Pentron Clinical Technologies | 2006 | 2 |
| 0 (this device) | K102703 | Build-IT Total Core | Pentron Clinical | 2011 | — |
| +1 | K153127 | everX Posterior | GC America, Inc. | 2016 | — |
| +1 | K231263 | Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT | Prevest Denpro Limited | 2024 | — |
| +2 | K192260 | everX Flow | GC America, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 1 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K000211 | Build-IT FRSummary page 1…te Restorative Material *Classification Name - Tooth Shade Resin Material, per 21 CFR § 872.3690 Devices for Which Substantial Equivalence isClaimed: *Build-It F.R., K000211, Pentron Clinical *Cement-It All Purpose, K060698, Pentron Clinical Device Description: Build-it Total Core isa dual-cure, sel… | 2000 |
| * | K060698 | Cement-IT All Purpose, Model N97Summary page 1…th Shade Resin Material, per 21 CFR § 872.3690 Devices for Which Substantial Equivalence isClaimed: *Build-It F.R., K000211, Pentron Clinical *Cement-It All Purpose, K060698, Pentron Clinical Device Description: Build-it Total Core isa dual-cure, self-adhesive composite with a continuous fluoride rel… | 2006 |
What descends from it? (3)
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 7 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K153127 (GC America, Inc., 2016) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K000211.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
Build-It Total Core is indicated for use as a core build up material on vital and non-vital teeth, sealing root canal openings, cavity floor liner, post cementation, restorative material and dentin replacement material.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102703 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102703: Build-IT Total Core.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102703
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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