510(k) · Cleared
ClearedMulti-unit Abutment Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nobel Biocare AB · NHA Abutment, Implant, Dental, Endosseous
Cleared on Mar 16, 2017 as substantially equivalent to K072570 (Nobel Biocare AB, 2007) after a 297-day review. Its family tree reaches back 9 generations to 1990. 74 later devices descend from it.
- Decided
- Mar 16, 2017
- Review
- 297 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K894595 (1990). 23 ancestors in all. 74 later devices descend from it, 10 citing it directly.
- Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 5 generations between
- 3 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 2 generations backK062749 SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic…Nobel Biocare AB · 2006
- 1 generation backK072570 Nobelactive Multi Unit AbutmentNobel Biocare AB · 2007 · Recalled
- This deviceK161416 Multi-unit Abutment PlusNobel Biocare AB · 2017
- Descendant · cites it directly · 38 of its ownK191986 DESS Dental Smart SolutionsTerrats Medical SL · 2019
- Descendant · cites it directly · 22 of its ownK183518 Preat AbutmentsPreat Corporation · 2019 · Recalled
- Descendant · 2 generations on · 20 of its ownK212628 DESS Dental Smart SolutionsTerrats Medical SL · 2022
- Descendant · 2 generations on · 19 of its ownK212577 DESS Dental Smart SolutionsTerrats Medical SL · 2021
- Descendant · 2 generations on · 15 of its ownK203464 DESS Dental Smart SolutionsTerrats Medical SL · 2021
Show all 9 generations
- Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 8 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 7 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 6 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 5 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 4 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 3 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 2 generations backK062749 SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic…Nobel Biocare AB · 2006
- 1 generation backK072570 Nobelactive Multi Unit AbutmentNobel Biocare AB · 2007 · Recalled
- This deviceK161416 Multi-unit Abutment PlusNobel Biocare AB · 2017
Showing 5 of 74 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 74 · See all- K191986DESS Dental Smart SolutionsTerrats Medical SL · 2019 · cites it directly38descendants
- K183518Preat AbutmentsPreat Corporation · 2019 · cites it directly22descendants
- K212628DESS Dental Smart SolutionsTerrats Medical SL · 2022 · 2 generations on20descendants
- K212577DESS Dental Smart SolutionsTerrats Medical SL · 2021 · 2 generations on19descendants
- K203464DESS Dental Smart SolutionsTerrats Medical SL · 2021 · 2 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −8 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −7 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −6 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −5 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −4 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −3 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −2 | K062749 | SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic Abutment 1MM RP… | Nobel Biocare AB | 2006 | — |
| −1 | K072570 | Nobelactive Multi Unit Abutment | Nobel Biocare AB | 2007 | 1 |
| 0 (this device) | K161416 | Multi-unit Abutment Plus | Nobel Biocare AB | 2017 | — |
| +1 | K191986 | DESS Dental Smart Solutions | Terrats Medical SL | 2019 | — |
| +1 | K183518 | Preat Abutments | Preat Corporation | 2019 | 3 |
| +2 | K212628 | DESS Dental Smart Solutions | Terrats Medical SL | 2022 | — |
| +2 | K212577 | DESS Dental Smart Solutions | Terrats Medical SL | 2021 | — |
| +2 | K203464 | DESS Dental Smart Solutions | Terrats Medical SL | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2002 | 3 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2020 | 6 | 0 |
| 2021 | 8 | 0 |
| 2022 | 10 | 0 |
| 2023 | 12 | 0 |
| 2024 | 7 | 0 |
| 2025 | 18 | 0 |
| 2026 | 11 | 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 |
|---|---|---|---|
| * | K072570 | Nobelactive Multi Unit AbutmentSummary page 4…Endosseous Dental Implant Abutment (21 CFR 872.3630) Regulatory Class: II Product Code: NHA III. PREDICATE DEVICE Primary Predicate: NobelActive Multi Unit Abutment - K072570 Reference Predicate NobelActive Wide Platform (WP) – K133731 IV. DEVICE DESCRIPTION Multi Unit Abutment Plus The Multi-unit Ab… | 2007 |
| † | K133731 | Nobelactive Wide Platform (WP) | 2014 |
What descends from it? (74)
See all 7410 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191986 | DESS Dental Smart Solutions | 2019 | 38 |
| K183518 | Preat Abutments | 2019 | 22 |
| K200992 | S.I.N. Dental Implant System | 2020 | 7 |
| K202344 | TiUltra Implants and Xeal Abutments | 2020 | 4 |
| K211109 | N1 TiUltra TCC Implant System | 2021 | 2 |
| K242064 | Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™) | 2025 | 1 |
| K221315 | UNIdental Symphony Implant System | 2023 | 1 |
| K251220 | NUVENTUS NV.C™ Prosthetic Components | 2025 | 0 |
| K221381 | KDG Abutments | 2022 | 0 |
| K200193 | Kisses Plus Implant System | 2021 | 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 27 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 5 of the 23 ancestors have a recall of any class.
- Of its descendants, K191986 (Terrats Medical SL, 2019) has gone furthest, with 38 descendants of its own.
- 17 other devices also cite its predicate K072570.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Multi-unit Abutment Plus is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161416 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161416: Multi-unit Abutment Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161416
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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