510(k) · Cleared
ClearedTetric Ceram
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ivoclar North America, Inc. · EBF Material, Tooth Shade, Resin
Cleared on Jan 22, 1997 after an 86-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it.
- Decided
- Jan 22, 1997
- Review
- 86 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 4 citing it directly.
- This deviceK964285 Tetric CeramIvoclar North America, Inc. · 1997
- Descendant · cites it directly · 1 of its ownK994268 Arabesk TopVoco GmbH · 2000
- Descendant · 2 generations on · 0 of its ownK063604 Twinky Star NFVoco GmbH · 2007
- Descendant · cites it directly · 0 of its ownK033996 Hermes3M Espe AG Dental Products · 2004
- Descendant · cites it directly · 0 of its ownK994304 Arabesk FlowVoco GmbH · 2000
- Descendant · cites it directly · 0 of its ownK982692 Sternomega Bonding Agent, Sternomega Composite LC, Sternomega…Sterngold/Implamed · 1998
Most influential descendants
Showing 5 of 5 · See all- K994268Arabesk TopVoco GmbH · 2000 · cites it directly1descendant
- K063604Twinky Star NFVoco GmbH · 2007 · 2 generations on0descendants
- K033996Hermes3M Espe AG Dental Products · 2004 · cites it directly0descendants
- K994304Arabesk FlowVoco GmbH · 2000 · cites it directly0descendants
- K982692Sternomega Bonding Agent, Sternomega Composite LC, Sternomega Compomer LCSterngold/Implamed · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964285 | Tetric Ceram | Ivoclar North America, Inc. | 1997 | — |
| +1 | K994268 | Arabesk Top | Voco GmbH | 2000 | — |
| +2 | K063604 | Twinky Star NF | Voco GmbH | 2007 | — |
| +1 | K033996 | Hermes | 3M Espe AG Dental Products | 2004 | — |
| +1 | K994304 | Arabesk Flow | Voco GmbH | 2000 | — |
| +1 | K982692 | Sternomega Bonding Agent, Sternomega Composite LC, Sternomega Compomer LC | Sterngold/Implamed | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (5)
4 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?
- Of its descendants, K994268 (Voco GmbH, 2000) has gone furthest, with 1 descendant of its own.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K964285 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964285: Tetric Ceram.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964285
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026