510(k) · Cleared
ClearedAluminum Oxide Powder, Sumicorundum AAO4S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Procera Sandvik, Inc. · EIH Powder, Porcelain
Cleared on Jul 5, 2000 after a 61-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 30 later devices descend from it.
- Decided
- Jul 5, 2000
- Review
- 61 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 0
30 later devices descend from it, 1 citing it directly.
- This deviceK001418 Aluminum Oxide Powder, Sumicorundum AAO4SProcera Sandvik, Inc. · 2000
- Descendant · cites it directly · 29 of its ownK032562 Proceara Copings and PonticNobel Biocare AB · 2004
- Descendant · 2 generations on · 15 of its ownK060530 SD Ceramic Coping for Quick Abutment, Locking. Model 45301. RD…Lifecore Biomedical, Inc. · 2006
- Descendant · 3 generations on · 7 of its ownK072241 Primaconnex Cad/Cam Abutment SystemLifecore Biomedical, Inc. · 2007
- Descendant · 3 generations on · 6 of its ownK062876 Primaconnex Ceramic AbutmentsLifecore Biomedical, Inc. · 2006
- Descendant · 2 generations on · 5 of its ownK041283 Procera Bridge ZirconiaNobel Biocare AB · 2004
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K032562Proceara Copings and PonticNobel Biocare AB · 2004 · cites it directly29descendants
- K060530SD Ceramic Coping for Quick Abutment, Locking. Model 45301. RD Ceramic Coping for Quick…Lifecore Biomedical, Inc. · 2006 · 2 generations on15descendants
- K072241Primaconnex Cad/Cam Abutment SystemLifecore Biomedical, Inc. · 2007 · 3 generations on7descendants
- K062876Primaconnex Ceramic AbutmentsLifecore Biomedical, Inc. · 2006 · 3 generations on6descendants
- K041283Procera Bridge ZirconiaNobel Biocare AB · 2004 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001418 | Aluminum Oxide Powder, Sumicorundum AAO4S | Procera Sandvik, Inc. | 2000 | — |
| +1 | K032562 | Proceara Copings and Pontic | Nobel Biocare AB | 2004 | — |
| +2 | K060530 | SD Ceramic Coping for Quick Abutment, Locking. Model 45301. RD Ceramic Coping… | Lifecore Biomedical, Inc. | 2006 | — |
| +3 | K072241 | Primaconnex Cad/Cam Abutment System | Lifecore Biomedical, Inc. | 2007 | — |
| +3 | K062876 | Primaconnex Ceramic Abutments | Lifecore Biomedical, Inc. | 2006 | — |
| +2 | K041283 | Procera Bridge Zirconia | Nobel Biocare AB | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2006 | 5 | 0 |
| 2007 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 4 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 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 EIH? 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 EIH device
- #1 K192231 Dental Glass Ceramics Blocksscore 15.2 · 3 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? (30)
See all 301 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032562 | Proceara Copings and Pontic | 2004 | 29 |
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, K032562 (Nobel Biocare AB, 2004) has gone furthest, with 29 descendants of its own.
How does its category compare?
All EIH devicesEIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EIH
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EIH
84in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EIH
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EIH
1in 2025
MAUDE reports naming product code EIH, 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 | 15 | 63 | 0 | 0 |
| 2008 | 15 | 87 | 0 | 1 |
| 2009 | 15 | 79 | 0 | 0 |
| 2010 | 14 | 89 | 0 | 0 |
| 2011 | 14 | 80 | 0 | 1 |
| 2012 | 9 | 96 | 0 | 0 |
| 2013 | 16 | 107 | 0 | 6 |
| 2014 | 18 | 118 | 0 | 1 |
| 2015 | 23 | 118 | 0 | 0 |
| 2016 | 22 | 187 | 21 | 4 |
| 2017 | 16 | 149 | 0 | 1 |
| 2018 | 10 | 139 | 0 | 2 |
| 2019 | 16 | 125 | 0 | 1 |
| 2020 | 13 | 155 | 0 | 0 |
| 2021 | 17 | 131 | 0 | 22 |
| 2022 | 16 | 89 | 0 | 0 |
| 2023 | 15 | 114 | 0 | 0 |
| 2024 | 28 | 89 | 0 | 7 |
| 2025 | 13 | 84 | 1 | 1 |
| 2026 | 14 | 73 | 0 | — |
https://510kreport.com/device/K001418 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001418: Aluminum Oxide Powder, Sumicorundum AAO4S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001418
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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