510(k) · Cleared
ClearedNobelprocera Ips E.Max Crown
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nobel Biocare AB · EIH Powder, Porcelain
Cleared on Aug 20, 2010 as substantially equivalent to K032562 (Nobel Biocare AB, 2004) and 1 other predicate after a 179-day review. Its family tree reaches back 2 generations to 1991. 1 later device descends from it.
- Decided
- Aug 20, 2010
- Review
- 179 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K910611 (1991). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK910611 Nobelpharma Ceraone Abutment SystemNobelpharma USA, Inc. · 1991
- 1 generation backK032562 Proceara Copings and PonticNobel Biocare AB · 2004
- This deviceK100512 Nobelprocera Ips E.Max CrownNobel Biocare AB · 2010
- Descendant · cites it directly · 0 of its ownK162677 L- OVCRhondium, Ltd. · 2016
Most influential descendants
Showing 1 of 1 · See all- K162677L- OVCRhondium, Ltd. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K910611 | Nobelpharma Ceraone Abutment System | Nobelpharma USA, Inc. | 1991 | — |
| −1 | K032562 | Proceara Copings and Pontic | Nobel Biocare AB | 2004 | — |
| 0 (this device) | K100512 | Nobelprocera Ips E.Max Crown | Nobel Biocare AB | 2010 | — |
| +1 | K162677 | L- OVC | Rhondium, Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 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 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? (2)
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 |
|---|---|---|---|
| * | K032562 | Proceara Copings and PonticSummary page 1…ct code EIH Trade or Proprietary or Model Name: NobelProcera IPS e~max Crown Legally Marketed Device(s): Procera Copings and Pontic (K032562) IPS e~max CAD/IPS e~max Zircad (KO051705) NobelProcera IPS e~max CAD Crowns are core s… | 2004 |
| * | K051705 | Ips E.Max Cad/Ips E.Max ZircadSummary page 1…ra IPS e~max Crown Legally Marketed Device(s): Procera Copings and Pontic (K032562) IPS e~max CAD/IPS e~max Zircad (KO051705) NobelProcera IPS e~max CAD Crowns are core superstructures intended for the fabrication of crowns. They are made of lithium di… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162677 | L- OVC | 2016 | 0 |
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 19 years and passes through 2 companies; a new generation was cleared every 12.5 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K162677 (Rhondium, Ltd., 2016) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K032562.
How does its category compare?
All EIH devicesEIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The NobeiProcera IPS e.max Crown is indicated for use as core structures of crowns that will be cemented to natural or artificial tooth abutments in the treatment of partially edentulous patients as an aid in prosthetic rehabilitation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100512 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100512: Nobelprocera Ips E.Max Crown.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100512
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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