510(k) · Cleared
ClearedOn1 Universal Abutment
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 Dec 12, 2018 as substantially equivalent to K161655 (Nobel Biocare AB, 2017) after a 153-day review. Its family tree reaches back 2 generations to 2014. 6 later devices descend from it.
- Decided
- Dec 12, 2018
- Review
- 153 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K132746 (2014). 6 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK132746 Nobelprocera Angulated Screw Channel Abutment Conical ConnectionNobel Biocare USA, LLC · 2014 · Recalled
- 1 generation backK161655 On1 ConceptNobel Biocare AB · 2017
- This deviceK181869 On1 Universal AbutmentNobel Biocare AB · 2018
- Descendant · cites it directly · 4 of its ownK202344 TiUltra Implants and Xeal AbutmentsNobel Biocare AB · 2020
- Descendant · cites it directly · 2 of its ownK211109 N1 TiUltra TCC Implant SystemNobel Biocare Services AG · 2021 · Recalled
- Descendant · 2 generations on · 1 of its ownK220048 NobelProcera Zirconia N1 BaseNobel Biocare Services AG · 2022
- Descendant · 2 generations on · 0 of its ownK253999 Universal Base ASC Engaging; Universal Base ASC Non-Engaging…Nobel Biocare AB · 2026
- Descendant · 2 generations on · 0 of its ownK252197 Nobel Biocare S Series ImplantsNobel Biocare AB · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K202344TiUltra Implants and Xeal AbutmentsNobel Biocare AB · 2020 · cites it directly4descendants
- K211109N1 TiUltra TCC Implant SystemNobel Biocare Services AG · 2021 · cites it directly2descendants
- K220048NobelProcera Zirconia N1 BaseNobel Biocare Services AG · 2022 · 2 generations on1descendant
- K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC…Nobel Biocare AB · 2026 · 2 generations on0descendants
- K252197Nobel Biocare S Series ImplantsNobel Biocare AB · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K132746 | Nobelprocera Angulated Screw Channel Abutment Conical Connection | Nobel Biocare USA, LLC | 2014 | 5 |
| −1 | K161655 | On1 Concept | Nobel Biocare AB | 2017 | — |
| 0 (this device) | K181869 | On1 Universal Abutment | Nobel Biocare AB | 2018 | — |
| +1 | K202344 | TiUltra Implants and Xeal Abutments | Nobel Biocare AB | 2020 | — |
| +1 | K211109 | N1 TiUltra TCC Implant System | Nobel Biocare Services AG | 2021 | 2 |
| +2 | K220048 | NobelProcera Zirconia N1 Base | Nobel Biocare Services AG | 2022 | — |
| +2 | K253999 | Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base… | Nobel Biocare AB | 2026 | — |
| +2 | K252197 | Nobel Biocare S Series Implants | Nobel Biocare AB | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 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 |
|---|---|---|---|
| * | K161655 | On1 ConceptSummary page 4…ion Name: Endosseous Dental Implant (21 CFR 872.3630) Regulatory Class: II Primary Product Code: NHA Secondary Product Code: PNP III.PREDICATE DEVICE Primary Predicate K161655, Nobel Biocare AB - On1 Concept Reference Devices K153645, Vita Zahnfabrik H. Rauter GmbH Co – Vita Enamic® Implant Solutions (I… | 2017 |
| † | K153645 | VITA ENAMIC Implant Solutions (IS) | 2016 |
| † | K111421 | Sirona Dental Cad/Cam System | 2012 |
| † | K181359 | InterActive SMARTBase Abutments | 2018 |
| † | K151455 | 3Shape Abutment Designer Software | 2016 |
| † | K130436 | Multilink Hybrid Abutment Cement | 2013 |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 4 years and passes through 2 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K202344 (Nobel Biocare AB, 2020) has gone furthest, with 4 descendants of its own.
- 4 other devices also cite its predicate K161655.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 On1™ device is a premanufactured prosthetic component directly connected to an endosseous implant and it is intended for use in prosthetic rehabilitation. The On1 Universal Abutments consist of three major parts. Specifically, the On1 Base, the On1 Universal Abutment, and the mesostructure components make up a multi-piece abutment. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.
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/K181869 · printed Nov 5, 2026
Cite this page
510(k) Report. “K181869: On1 Universal Abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K181869
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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