510(k) · Cleared
ClearedAngled Tapered Abutment
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer Dental, Inc. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Dec 8, 2011 after a 162-day review. The FDA summary names its predicate without a number. 8 later devices descend from it.
- Decided
- Dec 8, 2011
- Review
- 162 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 1 citing it directly.
- This deviceK111853 Angled Tapered AbutmentZimmer Dental, Inc. · 2011
- Descendant · cites it directly · 7 of its ownK121688 Multi-Unit Abutments with Angulations 17 and 30 for Tapered Implant…Prismatik Dentalcraft, Inc. · 2012
- Descendant · 2 generations on · 6 of its ownK140728 Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision…Ditron Precision, Ltd. · 2014
- Descendant · 3 generations on · 2 of its ownK203240 AccelX AbutmentsIntegrated Dental Systems, LLC · 2021
- Descendant · 4 generations on · 1 of its ownK252585 ZENEX Implant System_R-SystemIzenimplant Co., Ltd. · 2026
- Descendant · 3 generations on · 1 of its ownK161497 Dental Implants and AbutmentsDitron Precision, Ltd. · 2016
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K121688Multi-Unit Abutments with Angulations 17 and 30 for Tapered Implant SystemPrismatik Dentalcraft, Inc. · 2012 · cites it directly7descendants
- K140728Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece…Ditron Precision, Ltd. · 2014 · 2 generations on6descendants
- K203240AccelX AbutmentsIntegrated Dental Systems, LLC · 2021 · 3 generations on2descendants
- K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd. · 2026 · 4 generations on1descendant
- K161497Dental Implants and AbutmentsDitron Precision, Ltd. · 2016 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K111853 | Angled Tapered Abutment | Zimmer Dental, Inc. | 2011 | — |
| +1 | K121688 | Multi-Unit Abutments with Angulations 17 and 30 for Tapered Implant System | Prismatik Dentalcraft, Inc. | 2012 | — |
| +2 | K140728 | Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi -… | Ditron Precision, Ltd. | 2014 | — |
| +3 | K203240 | AccelX Abutments | Integrated Dental Systems, LLC | 2021 | — |
| +4 | K252585 | ZENEX Implant System_R-System | Izenimplant Co., Ltd. | 2026 | — |
| +3 | K161497 | Dental Implants and Abutments | Ditron Precision, Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | — | NobelActive Multi Unit Abutment Named without a submission number | |
| * | — | Tapered Abutment Named without a submission number |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121688 | Multi-Unit Abutments with Angulations 17 and 30 for Tapered Implant System | 2012 | 7 |
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, K121688 (Prismatik Dentalcraft, Inc., 2012) has gone furthest, with 7 descendants of its own.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
The Angled Tapered Abutment is used for a terminal or intermediate abutment for screw-retained multiple-unit restorations. The 30° Angled Tapered Abutment must be used within 45 degree of parallelism for a splinted restoration. The 15° Angled Tapered Abutment must be used within 30 degrees of parallelism for a splinted restoration.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111853 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111853: Angled Tapered Abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111853
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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