510(k) · Cleared
ClearedCavit-W
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Espe GmbH (Us) · EBG Crown And Bridge, Temporary, Resin
Cleared on Mar 1, 1988 after a 77-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.
- Decided
- Mar 1, 1988
- Review
- 77 days
- Class
- Class II
- Product code
- EBG
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 3 citing it directly.
- This deviceK875133 Cavit-WEspe GmbH (Us) · 1988
- Descendant · cites it directly · 7 of its ownK092715 Iroot BP PlusInnovative Bioceramix, Inc. · 2009
- Descendant · 2 generations on · 2 of its ownK102867 Iroot FSInnovative Bioceramix, Inc. · 2010
- Descendant · 2 generations on · 1 of its ownK240365 Bioceramic Root Repair Material (C-Root BP)Beijing C-Root Dental Medical Devices Co., Ltd. · 2024
- Descendant · cites it directly · 1 of its ownK061530 MD-TempMeta Biomed Co., Ltd. · 2006
- Descendant · 2 generations on · 0 of its ownK251465 Root canal repair materials (nRoot BP)Enpuno Biotechnology Co., Ltd. · 2025
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K092715Iroot BP PlusInnovative Bioceramix, Inc. · 2009 · cites it directly7descendants
- K102867Iroot FSInnovative Bioceramix, Inc. · 2010 · 2 generations on2descendants
- K240365Bioceramic Root Repair Material (C-Root BP)Beijing C-Root Dental Medical Devices Co., Ltd. · 2024 · 2 generations on1descendant
- K061530MD-TempMeta Biomed Co., Ltd. · 2006 · cites it directly1descendant
- K251465Root canal repair materials (nRoot BP)Enpuno Biotechnology Co., Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K875133 | Cavit-W | Espe GmbH (Us) | 1988 | — |
| +1 | K092715 | Iroot BP Plus | Innovative Bioceramix, Inc. | 2009 | — |
| +2 | K102867 | Iroot FS | Innovative Bioceramix, Inc. | 2010 | — |
| +2 | K240365 | Bioceramic Root Repair Material (C-Root BP) | Beijing C-Root Dental Medical Devices Co., Ltd. | 2024 | — |
| +1 | K061530 | MD-Temp | Meta Biomed Co., Ltd. | 2006 | — |
| +2 | K251465 | Root canal repair materials (nRoot BP) | Enpuno Biotechnology Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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 EBG? 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 EBG device
- #1 K253380 “FLNT Base” and “FLNT Temp”score 12.4 · 6 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (11)
See all 113 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, K092715 (Innovative Bioceramix, Inc., 2009) has gone furthest, with 7 descendants of its own.
How does its category compare?
All EBG devicesEBG Crown And Bridge, Temporary, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EBG
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBG
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBG
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBG
1in 2025
MAUDE reports naming product code EBG, 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 | 3 | 64 | 0 | 4 |
| 2008 | 9 | 83 | 0 | 4 |
| 2009 | 2 | — | 1 | 1 |
| 2010 | 5 | 103 | 0 | 1 |
| 2011 | 10 | 96 | 0 | 1 |
| 2012 | 5 | 90 | 0 | 5 |
| 2013 | 2 | — | 0 | 11 |
| 2014 | 3 | 114 | 0 | 23 |
| 2015 | 6 | 209 | 0 | 26 |
| 2016 | 4 | 163 | 0 | 8 |
| 2017 | 2 | — | 0 | 4 |
| 2018 | 4 | 202 | 0 | 0 |
| 2019 | 6 | 98 | 0 | 6 |
| 2020 | 14 | 194 | 1 | 2 |
| 2021 | 3 | 265 | 0 | 4 |
| 2022 | 3 | 73 | 0 | 2 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 5 | 144 | 0 | 0 |
| 2025 | 4 | 106 | 0 | 1 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K875133 · printed Nov 6, 2026
Cite this page
510(k) Report. “K875133: Cavit-W.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K875133
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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