510(k) · Cleared
ClearedIPS e.max CAD Abutment Solutions- extra systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ivoclar Vivadent, AG · NHA Abutment, Implant, Dental, Endosseous
Cleared on Aug 26, 2019 as substantially equivalent to K132209 (Ivoclar Vivadent, AG, 2013) after a 95-day review. Its family tree reaches back 12 generations to 1990. 3 later devices descend from it.
- Decided
- Aug 26, 2019
- Review
- 95 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K894844 (1990). 124 ancestors in all, the oldest K871863 (1987). 3 later devices descend from it, 1 citing it directly.
- Root · 12 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 8 generations between
- 3 generations backK100152 Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010
- 2 generations backK111421 Sirona Dental Cad/Cam SystemSirona Dental Systems GmbH · 2012
- 1 generation backK132209 Ips E.Max Cad Abutment SolutionsIvoclar Vivadent, AG · 2013
- This deviceK191382 IPS e.max CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG · 2019
- Descendant · cites it directly · 2 of its ownK221402 CEREC Tessera Abutment Block, CEREC Tessera Abutment SystemDentsply Sirona, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK252248 CEREC Tessera Abutment SystemDentsply Sirona · 2025
- Descendant · 2 generations on · 0 of its ownK234018 CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment SystemDentsply Sirona · 2024
Show all 12 generations
- Root · 12 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 11 generations backK990342 Synocta ProstheticsStraumann USA · 1999
- 10 generations backK013798 Prosthetic Accessories to the Iti Dental Implant SystemInstitut Straumann AG · 2001
- 9 generations backK020096 Esthetic Ease Abutments for the Iti Dental Implant SystemInstitut Straumann AG · 2002 · Recalled
- 8 generations backK033243 Iti Synocta Meso AbutmentsStraumann USA · 2003
- 7 generations backK052272 Straumann Computer Aided Restoration ServiceStraumann USA · 2006
- 6 generations backK061277 Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic…Straumann USA · 2007
- 5 generations backK072151 P.004 RC Cares Titanium and Ceramic AbutmentsStraumann USA · 2007 · Recalled
- 4 generations backK081005 P.004 NC Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008 · Recalled
- 3 generations backK100152 Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010
- 2 generations backK111421 Sirona Dental Cad/Cam SystemSirona Dental Systems GmbH · 2012
- 1 generation backK132209 Ips E.Max Cad Abutment SolutionsIvoclar Vivadent, AG · 2013
- This deviceK191382 IPS e.max CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG · 2019
Most influential descendants
Showing 3 of 3 · See all- K221402CEREC Tessera Abutment Block, CEREC Tessera Abutment SystemDentsply Sirona, Inc. · 2023 · cites it directly2descendants
- K252248CEREC Tessera Abutment SystemDentsply Sirona · 2025 · 2 generations on0descendants
- K234018CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment SystemDentsply Sirona · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −11 | K990342 | Synocta Prosthetics | Straumann USA | 1999 | — |
| −10 | K013798 | Prosthetic Accessories to the Iti Dental Implant System | Institut Straumann AG | 2001 | — |
| −9 | K020096 | Esthetic Ease Abutments for the Iti Dental Implant System | Institut Straumann AG | 2002 | 1 |
| −8 | K033243 | Iti Synocta Meso Abutments | Straumann USA | 2003 | — |
| −7 | K052272 | Straumann Computer Aided Restoration Service | Straumann USA | 2006 | — |
| −6 | K061277 | Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic Coping | Straumann USA | 2007 | — |
| −5 | K072151 | P.004 RC Cares Titanium and Ceramic Abutments | Straumann USA | 2007 | 1 |
| −4 | K081005 | P.004 NC Cares Titanium and Ceramic Abutments | Institut Straumann AG | 2008 | 1 |
| −3 | K100152 | Sirona Cad/Cam System | Sirona Dental Systems GmbH | 2010 | — |
| −2 | K111421 | Sirona Dental Cad/Cam System | Sirona Dental Systems GmbH | 2012 | — |
| −1 | K132209 | Ips E.Max Cad Abutment Solutions | Ivoclar Vivadent, AG | 2013 | — |
| 0 (this device) | K191382 | IPS e.max CAD Abutment Solutions- extra systems | Ivoclar Vivadent, AG | 2019 | — |
| +1 | K221402 | CEREC Tessera Abutment Block, CEREC Tessera Abutment System | Dentsply Sirona, Inc. | 2023 | — |
| +2 | K252248 | CEREC Tessera Abutment System | Dentsply Sirona | 2025 | — |
| +2 | K234018 | CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment System | Dentsply Sirona | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 11 | 0 |
| 1994 | 10 | 0 |
| 1995 | 8 | 0 |
| 1996 | 10 | 0 |
| 1997 | 4 | 0 |
| 1998 | 6 | 0 |
| 1999 | 6 | 0 |
| 2000 | 5 | 0 |
| 2001 | 5 | 0 |
| 2002 | 10 | 0 |
| 2003 | 4 | 0 |
| 2004 | 6 | 0 |
| 2005 | 4 | 0 |
| 2006 | 7 | 0 |
| 2007 | 4 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 NHA? 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 NHA device
- #1 K222288 DESS Dental Smart Solutionsscore 30.6 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K132209 | Ips E.Max Cad Abutment SolutionsSummary page 7…Dental Laboratory (872.3630) (Classification Code PNP) Predicate/Reference Devices: IPS e.max® CAD Abutment Solutions (K132209) by Ivoclar Vivadent, AG K100152 Sirona CAD/CAM Sys… | 2013 |
| † | K100152 | Sirona Cad/Cam System | 2010 |
| † | K111421 | Sirona Dental Cad/Cam System | 2012 |
| † | K181520 | Sirona Dental CAD/CAM System | 2018 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221402 | CEREC Tessera Abutment Block, CEREC Tessera Abutment System | 2023 | 2 |
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 29 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 17 of the 124 ancestors have a recall of any class.
- Of its descendants, K221402 (Dentsply Sirona, Inc., 2023) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K132209.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · NHA
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NHA
147in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHA
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHA
838in 2025
MAUDE reports naming product code NHA, 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 | 38 | 91 | 1 | 1 |
| 2008 | 31 | 90 | 2 | 8 |
| 2009 | 30 | 95 | 0 | 30 |
| 2010 | 19 | 162 | 0 | 61 |
| 2011 | 31 | 130 | 5 | 56 |
| 2012 | 25 | 171 | 1 | 5 |
| 2013 | 22 | 184 | 1 | 143 |
| 2014 | 27 | 160 | 0 | 146 |
| 2015 | 29 | 151 | 1 | 858 |
| 2016 | 38 | 202 | 36 | 314 |
| 2017 | 31 | 188 | 2 | 577 |
| 2018 | 31 | 200 | 1 | 591 |
| 2019 | 28 | 160 | 0 | 530 |
| 2020 | 38 | 153 | 7 | 458 |
| 2021 | 29 | 211 | 0 | 546 |
| 2022 | 33 | 142 | 0 | 497 |
| 2023 | 51 | 147 | 3 | 618 |
| 2024 | 43 | 158 | 0 | 635 |
| 2025 | 40 | 147 | 1 | 838 |
| 2026 | 23 | 169 | 3 | — |
What is it indicated for?
IPS e.max CAD Abutment Solutions is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations. The system comprises three parts: - IPS e.max CAD ceramic structure - Ti base - CAD/CAM system. The IPS e.max CAD ceramic structure cemented to the Ti base is recommended for two-piece hybrid abutments for single tooth restorations and hybrid abutment crowns, used in conjunction with endosseous…
Read the full statement (146 words)
IPS e.max CAD Abutment Solutions is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations.
The system comprises three parts:
- IPS e.max CAD ceramic structure
- Ti base
- CAD/CAM system.
The IPS e.max CAD ceramic structure cemented to the Ti base is recommended for two-piece hybrid abutments for single tooth restorations and hybrid abutment crowns, used in conjunction with endosseous dental implants.
The compatible Implant systems, titanium bases and CAD/CAM systems are shown below:
-Implant Systems:
- Dentsply Sirona: AstraTech OsseoSpeed, Frialit/Xive (K130999, K013867)
- BioHorizons Implant System: Internal Connection (K143022, K071638, K093321, K042429),
- Osstem: TS Implant System (K121585)
- Straumann: Tissue Level RN/WN (K061176)
- Nobel Biocare: Branemark (K022562)
- Zimmer: Tapered Screw-Vent (K061410)
- Camlog: Camlog Screw-Line, Conelog Screw-Line, iSy (K083496, K113779, K133991)
- CAD/CAM Systems: Sirona Dental CAD/CAM System (K181520)
-Titanium Bases:
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K191382 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191382: IPS e.max CAD Abutment Solutions- extra systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191382
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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