510(k) · Cleared
ClearedIps E.Max Cad Abutment Solutions
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 Oct 31, 2013 as substantially equivalent to K111421 (Sirona Dental Systems GmbH, 2012) and 3 other predicates after a 107-day review. Its family tree reaches back 11 generations to 1990. 39 later devices descend from it.
- Decided
- Oct 31, 2013
- Review
- 107 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 11 generations to K894844 (1990). 123 ancestors in all, the oldest K871863 (1987). 39 later devices descend from it, 5 citing it directly.
- Root · 11 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 7 generations between
- 3 generations backK081005 P.004 NC Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008 · Recalled
- 2 generations backK100152 Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010
- 1 generation backK111421 Sirona Dental Cad/Cam SystemSirona Dental Systems GmbH · 2012
- This deviceK132209 Ips E.Max Cad Abutment SolutionsIvoclar Vivadent, AG · 2013
- Descendant · cites it directly · 30 of its ownK142890 Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN…Straumann USA, LLC · 2015
- Descendant · 2 generations on · 13 of its ownK151324 Straumann Variobase for CERECStraumann USA, LLC · 2015
- Descendant · 3 generations on · 7 of its ownK171532 TruBase STruabutment, Inc. · 2018
- Descendant · 4 generations on · 6 of its ownK201197 TruAbutment DS, TruBase STruabutment, Inc. · 2021
- Descendant · 2 generations on · 5 of its ownK162890 BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and…Straumann USA, LLC · 2017
Show all 11 generations
- Root · 11 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 10 generations backK990342 Synocta ProstheticsStraumann USA · 1999
- 9 generations backK013798 Prosthetic Accessories to the Iti Dental Implant SystemInstitut Straumann AG · 2001
- 8 generations backK020096 Esthetic Ease Abutments for the Iti Dental Implant SystemInstitut Straumann AG · 2002 · Recalled
- 7 generations backK033243 Iti Synocta Meso AbutmentsStraumann USA · 2003
- 6 generations backK052272 Straumann Computer Aided Restoration ServiceStraumann USA · 2006
- 5 generations backK061277 Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic…Straumann USA · 2007
- 4 generations backK072151 P.004 RC Cares Titanium and Ceramic AbutmentsStraumann USA · 2007 · Recalled
- 3 generations backK081005 P.004 NC Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008 · Recalled
- 2 generations backK100152 Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010
- 1 generation backK111421 Sirona Dental Cad/Cam SystemSirona Dental Systems GmbH · 2012
- This deviceK132209 Ips E.Max Cad Abutment SolutionsIvoclar Vivadent, AG · 2013
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K142890Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase…Straumann USA, LLC · 2015 · cites it directly30descendants
- K151324Straumann Variobase for CERECStraumann USA, LLC · 2015 · 2 generations on13descendants
- K171532TruBase STruabutment, Inc. · 2018 · 3 generations on7descendants
- K201197TruAbutment DS, TruBase STruabutment, Inc. · 2021 · 4 generations on6descendants
- K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…Straumann USA, LLC · 2017 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −10 | K990342 | Synocta Prosthetics | Straumann USA | 1999 | — |
| −9 | K013798 | Prosthetic Accessories to the Iti Dental Implant System | Institut Straumann AG | 2001 | — |
| −8 | K020096 | Esthetic Ease Abutments for the Iti Dental Implant System | Institut Straumann AG | 2002 | 1 |
| −7 | K033243 | Iti Synocta Meso Abutments | Straumann USA | 2003 | — |
| −6 | K052272 | Straumann Computer Aided Restoration Service | Straumann USA | 2006 | — |
| −5 | K061277 | Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic Coping | Straumann USA | 2007 | — |
| −4 | K072151 | P.004 RC Cares Titanium and Ceramic Abutments | Straumann USA | 2007 | 1 |
| −3 | K081005 | P.004 NC Cares Titanium and Ceramic Abutments | Institut Straumann AG | 2008 | 1 |
| −2 | K100152 | Sirona Cad/Cam System | Sirona Dental Systems GmbH | 2010 | — |
| −1 | K111421 | Sirona Dental Cad/Cam System | Sirona Dental Systems GmbH | 2012 | — |
| 0 (this device) | K132209 | Ips E.Max Cad Abutment Solutions | Ivoclar Vivadent, AG | 2013 | — |
| +1 | K142890 | Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann… | Straumann USA, LLC | 2015 | — |
| +2 | K151324 | Straumann Variobase for CEREC | Straumann USA, LLC | 2015 | — |
| +3 | K171532 | TruBase S | Truabutment, Inc. | 2018 | — |
| +4 | K201197 | TruAbutment DS, TruBase S | Truabutment, Inc. | 2021 | — |
| +2 | K162890 | BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing… | Straumann USA, LLC | 2017 | — |
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 |
|---|---|---|
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 5 | 0 |
| 2018 | 5 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 7 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 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? (4)
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 |
|---|---|---|---|
| * | K111421 | Sirona Dental Cad/Cam System | 2012 |
| * | K051705 | Ips E.Max Cad/Ips E.Max ZircadSummary page 1…ion Name: Abutment, Implant, Dental Endosseous (872.3630) Predicate Devices: Sirona Dental CAD/CAM System (KI 11142 1) IPS e.max CAD (K05 1705) IPS e.max Press Abutment Solutions (K 120053 and K 124008) Device Description: IPS emax CAD Abut… | 2005 |
| * | K120053 | Ips E.Max Press - Abutment SolutionsSummary page 1…e Devices: Sirona Dental CAD/CAM System (KI 11142 1) IPS e.max CAD (K05 1705) IPS e.max Press Abutment Solutions (K 120053 and K 124008) Device Description: IPS emax CAD Abutment Solutions is intended for use in partially or fully edentulous man… | 2012 |
| * | K124008 | Ips E. Max Press Abutment Solutions for Nobel BiocareSummary page 1…Sirona Dental CAD/CAM System (KI 11142 1) IPS e.max CAD (K05 1705) IPS e.max Press Abutment Solutions (K 120053 and K 124008) Device Description: IPS emax CAD Abutment Solutions is intended for use in partially or fully edentulous mandibles and ma… | 2013 |
What descends from it? (39)
See all 395 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142890 | Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase… | 2015 | 30 |
| K191382 | IPS e.max CAD Abutment Solutions- extra systems | 2019 | 3 |
| K151564 | Telio CAD Abutment Solutions | 2015 | 1 |
| K171773 | Straumann n!ce Glass Ceramic A14 Blocks | 2017 | 0 |
| K153645 | VITA ENAMIC Implant Solutions (IS) | 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 23 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 17 of the 123 ancestors have a recall of any class.
- Of its descendants, K142890 (Straumann USA, LLC, 2015) has gone furthest, with 30 descendants of its own.
- 6 other devices also cite its predicate K111421.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 emax 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 mesostructure, Ti base and CAD/CAM software. The IPS e.max CAD mesostructure 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…
Read the full statement (244 words)
IPS emax 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 mesostructure,
Ti base and
CAD/CAM software.
The IPS e.max CAD mesostructure 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, Ti bases and CAD/CAM systems are shown below:
Implant systems: Nobel Biocare Replace (K020646), Nobel Biocare Activemn (K071370), Straumann Bone Level (K053088, K062129, K060958), Biomet 3i Osseotite (K980549)
CAD/CAM Systems: Sirona inLab and Cerec SW 4.2 and above
Titanium bases:
Implant Implant System - Implant TIBase * Sirona' Interface
manufacturer Diameter Ref. size
Nobel Biocare Replace NP 3.5 NBRS 3.5 6282474 L
_______Replace RP 4.3 NBRS 4.3 6282482 L
Replace WVP 5.0 NBRS 5.0 6282490 L
_______Replace 6.0 6.0 NBRS 6.0 6282508 L
Nobel Biocare Nobel Active NP 3.5 NB A 4.5 6208188 L
Nobel Active RP
I______ 4.3/5.0 1NB A 5.0 16208253 L
Straumann Bone Level NC 3.3 S BL 3.3 6308154 L
______Bone Level RC 4.1/4.8 88L 4.1 6308337 L
Biomet 3i Certain 3.4 BC 3.4 6308048 S
_______Certain 4.1 B 04.1 6305097 L
_______Certain 5.0 BC 5.0 16308121 L
For the titanium base Straumann Bone Level 3.3 L the indication is restricted for replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132209 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132209: Ips E.Max Cad Abutment Solutions.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132209
Report an extraction error
Are you the manufacturer?
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