510(k) · Cleared
Recalled · Class II · 2024Ips E.Max Cad/Ips E.Max Zircad
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ivoclar Vivadent, Inc. · EIH Powder, Porcelain
Cleared on Oct 14, 2005 after a 112-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 228 later devices descend from it. It has been recalled 10 times.
- Decided
- Oct 14, 2005
- Review
- 112 days
- Class
- Class II
- Product code
- EIH
- Recalls
- 10
- Predicates
- 0
228 later devices descend from it, 21 citing it directly.
- This deviceK051705 Ips E.Max Cad/Ips E.Max ZircadIvoclar Vivadent, Inc. · 2005
- Descendant · cites it directly · 186 of its ownK072569 Metoxit Cam-BlanksMetoxit AG · 2007
- Descendant · 2 generations on · 165 of its ownK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
- Descendant · 3 generations on · 129 of its ownK150203 Medentika CAD/CAM AbutmentsMedentika GmbH · 2015
- Descendant · 3 generations on · 89 of its ownK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- Descendant · 4 generations on · 86 of its ownK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
Showing 5 of 228 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 228 · See all- K072569Metoxit Cam-BlanksMetoxit AG · 2007 · cites it directly186descendants
- K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG · 2012 · 2 generations on165descendants
- K150203Medentika CAD/CAM AbutmentsMedentika GmbH · 2015 · 3 generations on129descendants
- K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015 · 3 generations on89descendants
- K170588DESS Dental Smart SolutionsTerrats Medical SL · 2017 · 4 generations on86descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K051705 | Ips E.Max Cad/Ips E.Max Zircad | Ivoclar Vivadent, Inc. | 2005 | — |
| +1 | K072569 | Metoxit Cam-Blanks | Metoxit AG | 2007 | — |
| +2 | K120822 | Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN… | Institut Straumann AG | 2012 | — |
| +3 | K150203 | Medentika CAD/CAM Abutments | Medentika GmbH | 2015 | — |
| +3 | K150367 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015 | — |
| +4 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 5 | 0 |
| 2015 | 14 | 0 |
| 2016 | 12 | 0 |
| 2017 | 11 | 0 |
| 2018 | 12 | 0 |
| 2019 | 8 | 0 |
| 2020 | 12 | 0 |
| 2021 | 22 | 0 |
| 2022 | 15 | 0 |
| 2023 | 27 | 0 |
| 2024 | 32 | 0 |
| 2025 | 27 | 0 |
| 2026 | 15 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (228)
See all 22821 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072569 | Metoxit Cam-Blanks | 2007 | 186 |
| K132209 | Ips E.Max Cad Abutment Solutions | 2013 | 39 |
| K100781 | Obsidian Ceramic Blocks | 2010 | 5 |
| K160262 | n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks, | 2016 | 4 |
| K230487 | Dental Lithium Disilicate Glass-Ceramic | 2023 | 2 |
| K211308 | Inni-Cera | 2021 | 1 |
| K142233 | zenostar MO, Zenostar T, Zenostar VisualiZr | 2015 | 1 |
| K100512 | Nobelprocera Ips E.Max Crown | 2010 | 1 |
| K081749 | Avante Z Zirconia (as)3 Blocks | 2008 | 1 |
| K073314 | Heany Industries Inc Dental Xirconia | 2008 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 5, 2024 | Class II | Z-1704-2024 | Under Investigation by firm | Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration |
| Apr 5, 2024 | Class II | Z-1703-2024 | Under Investigation by firm | Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration |
| Apr 5, 2024 | Class II | Z-1706-2024 | Under Investigation by firm | Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration |
| Apr 5, 2024 | Class II | Z-1707-2024 | Under Investigation by firm | Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration |
| Apr 5, 2024 | Class II | Z-1708-2024 | Under Investigation by firm | Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration |
| Apr 5, 2024 | Class II | Z-1705-2024 | Under Investigation by firm | Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration |
| Apr 13, 2020 | Class II | Z-1840-2020 | Process control | Restorations crack during the sintering process. |
| Apr 13, 2020 | Class II | Z-1838-2020 | Process control | Restorations crack during the sintering process. |
| Apr 13, 2020 | Class II | Z-1839-2020 | Process control | Restorations crack during the sintering process. |
| Apr 13, 2020 | Class II | Z-1837-2020 | Process control | Restorations crack during the sintering process. |
The 5 latest of 10 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K072569 (Metoxit AG, 2007) has gone furthest, with 186 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 | — |
What is it indicated for?
IPS e.max CAD is a CAD/CAM machinable glass ceramic based on lithium disilicate for the preparation of full ceramic crowns, inlays, onlays, and full ceramic 3-unit anterior bridges.
IPS e.max ZirCAD consists of machinable zirconia blocks for the preparation of full ceramic crowns, onlays and 3- and 4-unit bridges and inlay bridges (anterior and molar.)
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K051705 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051705: Ips E.Max Cad/Ips E.Max Zircad.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051705
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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