510(k) · Cleared
ClearedCerasmart
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 14, 2014 as substantially equivalent to K110131 (3M Espe Dental Products, 2011) and 2 other predicates after an 87-day review. Its family tree reaches back 3 generations to 2004. 32 later devices descend from it.
- Decided
- Mar 14, 2014
- Review
- 87 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K042819 (2004). 10 ancestors in all, the oldest K920425 (1992). 32 later devices descend from it, 5 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 deviceK133824 CerasmartGC America, Inc. · 2014
- Descendant · cites it directly · 26 of its ownK160425 CAD/CAMouflage Milling BockPrismatik Dentalcraft, Inc. · 2016
- Descendant · 2 generations on · 25 of its ownK162537 CAD/CAMouflage Milling BlockPrismatik Dentalcraft, Inc. · 2016
- Descendant · 3 generations on · 24 of its ownK201668 VarseoSmile Crown plusBego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG · 2020
- Descendant · 4 generations on · 13 of its ownK202846 Tera HarzGraphy, Inc. · 2021
- Descendant · 4 generations on · 7 of its ownK210977 E-Dent 1000Envisiontec GmbH · 2021
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K160425CAD/CAMouflage Milling BockPrismatik Dentalcraft, Inc. · 2016 · cites it directly26descendants
- K162537CAD/CAMouflage Milling BlockPrismatik Dentalcraft, Inc. · 2016 · 2 generations on25descendants
- K201668VarseoSmile Crown plusBego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG · 2020 · 3 generations on24descendants
- K202846Tera HarzGraphy, Inc. · 2021 · 4 generations on13descendants
- K210977E-Dent 1000Envisiontec GmbH · 2021 · 4 generations on7descendants
View 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) | K133824 | Cerasmart | GC America, Inc. | 2014 | — |
| +1 | K160425 | CAD/CAMouflage Milling Bock | Prismatik Dentalcraft, Inc. | 2016 | — |
| +2 | K162537 | CAD/CAMouflage Milling Block | Prismatik Dentalcraft, Inc. | 2016 | — |
| +3 | K201668 | VarseoSmile Crown plus | Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG | 2020 | — |
| +4 | K202846 | Tera Harz | Graphy, Inc. | 2021 | — |
| +4 | K210977 | E-Dent 1000 | Envisiontec GmbH | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 3 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 7 | 0 |
| 2025 | 3 | 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? (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 |
|---|---|---|---|
| * | K110131 | Lava Ultimate Cad/Cam Restorative for Cerec / E4D, Lava Ultimate Implant Crown RestorativeSummary page 2…name CERASMART LAVAUIfmate MFP-051 GRADIACORE (K110131) (K123631) (K082171) Manufacturer GC Corporation 3M ESPE… | 2011 |
| * | K123631 | MFP-051Summary page 2…LAVAUIfmate MFP-051 GRADIACORE (K110131) (K123631) (K082171) Manufacturer GC Corporation 3M ESPE GC Corporation… | 2013 |
| * | K082171 | Gradia CoreSummary page 1…America Inc. MFP-05 1 Ki123631 7/23/2013 GC AmericalInc. GRADIA CORE K082171 10/30/2008 4. Description of Device: CERASMART is a pro-cured composite block for milling CAD/CAM indirect re… | 2008 |
What descends from it? (32)
See all 325 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 10 years and passes through 2 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K160425 (Prismatik Dentalcraft, Inc., 2016) has gone furthest, with 26 descendants of its own.
- 4 other devices also cite its predicate K110131.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
The product is indicated for inlays, onlays, veneers and full crown restorations, including crowns an implants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133824 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133824: Cerasmart.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133824
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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