510(k) · Cleared
ClearedCAD/CAMouflage Milling Bock
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prismatik Dentalcraft, Inc. · EBF Material, Tooth Shade, Resin
Cleared on Jul 15, 2016 as substantially equivalent to K133824 (GC America, Inc., 2014) after a 150-day review. Its family tree reaches back 4 generations to 2004. 26 later devices descend from it.
- Decided
- Jul 15, 2016
- Review
- 150 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K042819 (2004). 11 ancestors in all, the oldest K920425 (1992). 26 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK042819 Tetric EvoceramIvoclar Vivadent, Inc. · 2004
- 3 generations backK091388 GCUC-505GC America, Inc. · 2009
- 2 generations backK123631 MFP-051GC America, Inc. · 2013
- 1 generation backK133824 CerasmartGC America, Inc. · 2014
- This deviceK160425 CAD/CAMouflage Milling BockPrismatik Dentalcraft, Inc. · 2016
- Descendant · cites it directly · 25 of its ownK162537 CAD/CAMouflage Milling BlockPrismatik Dentalcraft, Inc. · 2016
- Descendant · 2 generations on · 24 of its ownK201668 VarseoSmile Crown plusBego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG · 2020
- Descendant · 3 generations on · 13 of its ownK202846 Tera HarzGraphy, Inc. · 2021
- Descendant · 3 generations on · 7 of its ownK210977 E-Dent 1000Envisiontec GmbH · 2021
- Descendant · 4 generations on · 6 of its ownK213343 Saremco Print CROWNTECSaremco Dental AG · 2022
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K162537CAD/CAMouflage Milling BlockPrismatik Dentalcraft, Inc. · 2016 · cites it directly25descendants
- K201668VarseoSmile Crown plusBego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG · 2020 · 2 generations on24descendants
- K202846Tera HarzGraphy, Inc. · 2021 · 3 generations on13descendants
- K210977E-Dent 1000Envisiontec GmbH · 2021 · 3 generations on7descendants
- K213343Saremco Print CROWNTECSaremco Dental AG · 2022 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K042819 | Tetric Evoceram | Ivoclar Vivadent, Inc. | 2004 | — |
| −3 | K091388 | GCUC-505 | GC America, Inc. | 2009 | — |
| −2 | K123631 | MFP-051 | GC America, Inc. | 2013 | — |
| −1 | K133824 | Cerasmart | GC America, Inc. | 2014 | — |
| 0 (this device) | K160425 | CAD/CAMouflage Milling Bock | Prismatik Dentalcraft, Inc. | 2016 | — |
| +1 | K162537 | CAD/CAMouflage Milling Block | Prismatik Dentalcraft, Inc. | 2016 | — |
| +2 | K201668 | VarseoSmile Crown plus | Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG | 2020 | — |
| +3 | K202846 | Tera Harz | Graphy, Inc. | 2021 | — |
| +3 | K210977 | E-Dent 1000 | Envisiontec GmbH | 2021 | — |
| +4 | K213343 | Saremco Print CROWNTEC | Saremco Dental AG | 2022 | — |
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 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 6 | 0 |
| 2025 | 3 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | K133824 | CerasmartSummary page 5…C. IDENTIFICATION OF PREDICATE DEVICE Trade/Proprietary Name: CAD/CAMouflage Milling Block Primary Device: CERASMART™-K133824 Reference Device: Camouflage Nanohybrid Composite-K133850 D. DEVICE DESCRIPTION The CAD/CAMou… | 2014 |
| † | K133850 | Camouflage Nanohybrid Composite (Universal & Flowable) | 2014 |
What descends from it? (26)
See all 261 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162537 | CAD/CAMouflage Milling Block | 2016 | 25 |
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 12 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K162537 (Prismatik Dentalcraft, Inc., 2016) has gone furthest, with 25 descendants of its own.
- 4 other devices also cite its predicate K133824.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
CAD/CAMouflage Milling Block is indicated as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The CAD/CAMouflage Milling Block is made for fabricating temporary and permanent restorations such as inlays, onlays, veneers and full crown restorations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160425 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160425: CAD/CAMouflage Milling Bock.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160425
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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