510(k) Report

510(k) · Cleared

Cleared

Ips E.Max Press - Abutment Solutions

K120053510(k) TraditionalCleared Oct 18, 2012286-day reviewClass II21 CFR 872.3630

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ivoclar Vivadent, AG · NHA Abutment, Implant, Dental, Endosseous

Cleared on Oct 18, 2012 after a 286-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 42 later devices descend from it.

Decided
Oct 18, 2012
Review
286 days
Class
Class II
Product code
NHA
Recalls
None
Predicates
0

42 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2013: 2 descendants cleared2016: 4 descendants cleared2015: 4 descendants cleared2017: 5 descendants cleared2019: 1 descendant cleared2018: 5 descendants cleared2021: 7 descendants cleared2020: 2 descendants cleared2023: 3 descendants cleared2025: 4 descendants cleared2022: 2 descendants cleared2024: 3 descendants cleared2010201520202025
  1. This deviceK120053 Ips E.Max Press - Abutment SolutionsIvoclar Vivadent, AG · 2012
  2. Descendant · cites it directly · 40 of its ownK124008 Ips E. Max Press Abutment Solutions for Nobel BiocareIvoclar Vivadent, Agin · 2013
  3. Descendant · cites it directly · 39 of its ownK132209 Ips E.Max Cad Abutment SolutionsIvoclar Vivadent, AG · 2013
  4. Descendant · cites it directly · 30 of its ownK142890 Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN…Straumann USA, LLC · 2015
  5. Descendant · 2 generations on · 13 of its ownK151324 Straumann Variobase for CERECStraumann USA, LLC · 2015
  6. Descendant · 3 generations on · 7 of its ownK171532 TruBase STruabutment, Inc. · 2018

Showing 5 of 42 descendants. See all descendants

Descendants cleared per year

2013: 22015: 42016: 42017: 52018: 52019: 12020: 22021: 72022: 22023: 32024: 32025: 4
2013high 7 (2021) · low 0 (2014)2026

Most influential descendants

Showing 5 of 42 · See all
  • K124008Ips E. Max Press Abutment Solutions for Nobel BiocareIvoclar Vivadent, Agin · 2013 · cites it directly40descendants
  • K132209Ips E.Max Cad Abutment SolutionsIvoclar Vivadent, AG · 2013 · cites it directly39descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K120053Ips E.Max Press - Abutment SolutionsIvoclar Vivadent, AG2012—
+1K124008Ips E. Max Press Abutment Solutions for Nobel BiocareIvoclar Vivadent, Agin2013—
+1K132209Ips E.Max Cad Abutment SolutionsIvoclar Vivadent, AG2013—
+1K142890Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann…Straumann USA, LLC2015—
+2K151324Straumann Variobase for CERECStraumann USA, LLC2015—
+3K171532TruBase STruabutment, Inc.2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201320
201540
201640
201750
201850
201910
202020
202170
202220
202330
202430
202540
FIG. 1 — Lineage of K120053, 2012–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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 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. #1 K222288 DESS Dental Smart Solutionsscore 30.6 · 19 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (42)

See all 42

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K124008Ips E. Max Press Abutment Solutions for Nobel BiocareIvoclar Vivadent, Agin201340
K132209Ips E.Max Cad Abutment SolutionsIvoclar Vivadent, AG201339
K142890Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase…Straumann USA, LLC201530
K160798IPS e.max® Press Abutment Solutions for Viteo Base TiIvoclar Vivadent, AG20160

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?

  • Of its descendants, K124008 (Ivoclar Vivadent, Agin, 2013) has gone furthest, with 40 descendants of its own.

How does its category compare?

All NHA devices

NHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · NHA

40in 2025

2007: 382008: 312009: 302010: 192011: 312012: 252013: 222014: 272015: 292016: 382017: 312018: 312019: 282020: 382021: 292022: 332023: 512024: 432025: 402026 (partial year): 23
2007high 51 (2023) · low 19 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NHA

147in 2025

2007: 91 days median2008: 90 days median2009: 95 days median2010: 162 days median2011: 130 days median2012: 171 days median2013: 184 days median2014: 160 days median2015: 151 days median2016: 202 days median2017: 188 days median2018: 200 days median2019: 160 days median2020: 153 days median2021: 211 days median2022: 142 days median2023: 147 days median2024: 158 days median2025: 147 days median2026 (partial year): 169 days median
2007high 211 (2021) · low 90 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NHA

1in 2025

2007: 12008: 22011: 52012: 12013: 12015: 12016: 362017: 22018: 12020: 72023: 32025: 12026 (partial year): 3
2007high 36 (2016) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NHA

838in 2025

2007: 12008: 82009: 302010: 612011: 562012: 52013: 1432014: 1462015: 8582016: 3142017: 5772018: 5912019: 5302020: 4582021: 5462022: 4972023: 6182024: 6352025: 838
2007high 858 (2015) · low 1 (2007)2025

MAUDE reports naming product code NHA, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007389111
2008319028
20093095030
201019162061
201131130556
20122517115
2013221841143
2014271600146
2015291511858
20163820236314
2017311882577
2018312001591
2019281600530
2020381537458
2021292110546
2022331420497
2023511473618
2024431580635
2025401471838
2026231693—

What is it indicated for?

IPS e.max® Press Abutment Solutions is intended for use in partially or fully endentuous mandibles and maxillae in support of single or multiple-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

The following Ti bases are intended to be used with IPS emax Press Abutment Solutions.

Implant manufacture: Straumann®

Implant system, diameter: Bone Level RC, 4.1 mm or 4.8 mm

Compatible Ti base (abutment): RC Cementable abutment

Dimensions: D 5.0–6.5 mm; GH 1.0–3.0 mm; HTi 4.0–5.5 mm

Indications for use as stated in the FDA 510(k) statement.

More from Ivoclar Vivadent, AG

31 FDA decisions under this applicant name. See the company

  • K210804Adhese Universal DC, Cention PrimerIvoclar Vivadent, AG · 2022
  • K211916IPS e.max OneIvoclar Vivadent, AG · 2021
  • K193193Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG · 2020
  • K191453Cervitec FIvoclar Vivadent, AG · 2020
  • K191448Barrier SleevesIvoclar Vivadent, AG · 2019

Recent decisions in NHA

The NHA category page

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https://510kreport.com/device/K120053 · printed Nov 6, 2026

Cite this page

510(k) Report. “K120053: Ips E.Max Press - Abutment Solutions.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120053

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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