510(k) · Cleared
ClearedMulti-Unit Abutments with Angulations 17 and 30 for Tapered Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prismatik Dentalcraft, Inc. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Oct 12, 2012 as substantially equivalent to K111853 (Zimmer Dental, Inc., 2011) after a 127-day review. Its family tree reaches back 1 generation to 2011. 7 later devices descend from it.
- Decided
- Oct 12, 2012
- Review
- 127 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K111853 (2011). 7 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK111853 Angled Tapered AbutmentZimmer Dental, Inc. · 2011
- This deviceK121688 Multi-Unit Abutments with Angulations 17 and 30 for Tapered Implant…Prismatik Dentalcraft, Inc. · 2012
- Descendant · cites it directly · 6 of its ownK140728 Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision…Ditron Precision, Ltd. · 2014
- Descendant · 2 generations on · 2 of its ownK203240 AccelX AbutmentsIntegrated Dental Systems, LLC · 2021
- Descendant · 3 generations on · 1 of its ownK252585 ZENEX Implant System_R-SystemIzenimplant Co., Ltd. · 2026
- Descendant · 2 generations on · 1 of its ownK161497 Dental Implants and AbutmentsDitron Precision, Ltd. · 2016
- Descendant · 4 generations on · 0 of its ownK253334 ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd. · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K140728Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece…Ditron Precision, Ltd. · 2014 · cites it directly6descendants
- K203240AccelX AbutmentsIntegrated Dental Systems, LLC · 2021 · 2 generations on2descendants
- K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd. · 2026 · 3 generations on1descendant
- K161497Dental Implants and AbutmentsDitron Precision, Ltd. · 2016 · 2 generations on1descendant
- K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K111853 | Angled Tapered Abutment | Zimmer Dental, Inc. | 2011 | — |
| 0 (this device) | K121688 | Multi-Unit Abutments with Angulations 17 and 30 for Tapered Implant System | Prismatik Dentalcraft, Inc. | 2012 | — |
| +1 | K140728 | Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi -… | Ditron Precision, Ltd. | 2014 | — |
| +2 | K203240 | AccelX Abutments | Integrated Dental Systems, LLC | 2021 | — |
| +3 | K252585 | ZENEX Implant System_R-System | Izenimplant Co., Ltd. | 2026 | — |
| +2 | K161497 | Dental Implants and Abutments | Ditron Precision, Ltd. | 2016 | — |
| +4 | K253334 | ZENEX Implant System_Short (R-System) | Izenimplant Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K111853 | Angled Tapered AbutmentSummary page 3…ngled Comparison Multi-Unit Abutments with Tapered Abutment Angulations 170 and 300 for (K111853) Tapered Implant System Material Titanium… | 2011 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140728 | Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece… | 2014 | 6 |
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.
- Of its descendants, K140728 (Ditron Precision, Ltd., 2014) has gone furthest, with 6 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. 2012, 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?
Inclusive Multi-Unit Abutments are prosthetic components directly connected to endosseous dental implants and intended to provide support and retention* for multi-unit screw-retained restorations. The 30-degree multi-unit abutments must be used within 45 degrees of parallelism for a splinted restoration. The 17-degree multi-unit abutments must be used within 32 degrees of parallelism for a splinted restoration.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121688 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121688: Multi-Unit Abutments with Angulations 17 and 30 for Tapered Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121688
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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