510(k) · Cleared
ClearedIPS e.max® Press Abutment Solutions for Viteo Base Ti
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 Dec 15, 2016 as substantially equivalent to K120053 (Ivoclar Vivadent, AG, 2012) after a 267-day review. Its family tree reaches back 1 generation to 2012.
- Decided
- Dec 15, 2016
- Review
- 267 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K120053 (2012). No later device cites it as a predicate yet.
- Root · 1 generation backK120053 Ips E.Max Press - Abutment SolutionsIvoclar Vivadent, AG · 2012
- This deviceK160798 IPS e.max® Press Abutment Solutions for Viteo Base TiIvoclar Vivadent, AG · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K120053 | Ips E.Max Press - Abutment Solutions | Ivoclar Vivadent, AG | 2012 | — |
| 0 (this device) | K160798 | IPS e.max® Press Abutment Solutions for Viteo Base Ti | Ivoclar Vivadent, AG | 2016 | — |
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 30.7 · 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 |
|---|---|---|---|
| * | K120053 | Ips E.Max Press - Abutment SolutionsSummary page 5…nt part and the IPS e.max Press ceramic part included in the subject device. Primary Predicate Device: IPS e.max Press Abutment Solutions (K120053) Reference predicate device: IPS e.max Press Abutment Solutions for Nobel Biocare (… | 2012 |
| † | K124008 | Ips E. Max Press Abutment Solutions for Nobel Biocare | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate K120053.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Press Abutment Solutions for Viteo Base Ti is intended for use in partially or fully edentulous mandibles and maxillae in support of single or multi-unit cement retained restorations. IPS e.max Press Abutment Solutions is recommended for the fabrication of: - Hybrid abutments for single-tooth restorations - Hybrid abutment crowns for restorations IPS e.max Press Abutment Solutions for Viteo Base-Ti are compatible with the following Implant…
Read the full statement (131 words)
IPS e.max Press Abutment Solutions for Viteo Base Ti is intended for use in partially or fully edentulous mandibles and maxillae in support of single or multi-unit cement retained restorations.
IPS e.max Press Abutment Solutions is recommended for the fabrication of:
- Hybrid abutments for single-tooth restorations
- Hybrid abutment crowns for restorations
IPS e.max Press Abutment Solutions for Viteo Base-Ti are compatible with the following Implant Systems
Implant brand and type Clearance ID Platform and Implant Diameter(s)
Bone Level®
Straumann® Dental Implant System,
K150938 NC: 3.3 mm RC: 4.1, 4.8 mm
K130222
NobelActive®
Nobel Biocare®,
K071370 NP: 3.5 mm RP: 4.3, 5.0 mm
K041661
Osseotite®
Biomet 3i® Certain® BI-OC: 3.4 mm BI-OC: 4.1, 5.0 mm
K111216
OsseoSpeed®
Astra Tech AB
K101732 OS: 3.5, 4.0 mm OS: 4.5, 5.0 mm
K091239
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160798 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160798: IPS e.max® Press Abutment Solutions for Viteo Base Ti.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160798
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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