510(k) · Cleared
ClearedOn1 Concept
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 Feb 28, 2017 as substantially equivalent to K132746 (Nobel Biocare USA, LLC, 2014) after a 257-day review. Its family tree reaches back 1 generation to 2014. 10 later devices descend from it.
- Decided
- Feb 28, 2017
- Review
- 257 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K132746 (2014). 10 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK132746 Nobelprocera Angulated Screw Channel Abutment Conical ConnectionNobel Biocare USA, LLC · 2014 · Recalled
- This deviceK161655 On1 ConceptNobel Biocare AB · 2017
- Descendant · cites it directly · 6 of its ownK181869 On1 Universal AbutmentNobel Biocare AB · 2018
- Descendant · 2 generations on · 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 · cites it directly · 1 of its ownK220253 Eco Abutment, Multiunit AbutmentDio Corporation · 2023
- Descendant · cites it directly · 1 of its ownK220048 NobelProcera Zirconia N1 BaseNobel Biocare Services AG · 2022
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K181869On1 Universal AbutmentNobel Biocare AB · 2018 · cites it directly6descendants
- K202344TiUltra Implants and Xeal AbutmentsNobel Biocare AB · 2020 · 2 generations on4descendants
- K211109N1 TiUltra TCC Implant SystemNobel Biocare Services AG · 2021 · cites it directly2descendants
- K220253Eco Abutment, Multiunit AbutmentDio Corporation · 2023 · cites it directly1descendant
- K220048NobelProcera Zirconia N1 BaseNobel Biocare Services AG · 2022 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K132746 | Nobelprocera Angulated Screw Channel Abutment Conical Connection | Nobel Biocare USA, LLC | 2014 | 5 |
| 0 (this device) | K161655 | On1 Concept | Nobel Biocare AB | 2017 | — |
| +1 | K181869 | On1 Universal Abutment | Nobel Biocare AB | 2018 | — |
| +2 | K202344 | TiUltra Implants and Xeal Abutments | Nobel Biocare AB | 2020 | — |
| +1 | K211109 | N1 TiUltra TCC Implant System | Nobel Biocare Services AG | 2021 | 2 |
| +1 | K220253 | Eco Abutment, Multiunit Abutment | Dio Corporation | 2023 | — |
| +1 | K220048 | NobelProcera Zirconia N1 Base | Nobel Biocare Services AG | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K132746 | Nobelprocera Angulated Screw Channel Abutment Conical ConnectionSummary page 4…plant (21 CFR 872.3630) Regulatory Class: II Product Code: NHA III.PREDICATE DEVICE Primary Predicate NobelProcera Angulated Screw Channel Abutment Conical Connection (K132746) Reference Predicate NobelActive Wide Platform (WP) (K133731) IV. DEVICE DESCRIPTION The On1 Concept is a 2-piece dental impla… | 2014 |
| † | K133731 | Nobelactive Wide Platform (WP) | 2014 |
What descends from it? (10)
5 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?
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 On1™ device is a premanufactured prosthetic component directly connected to an endosseous implant and it is intended for use 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/K161655 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161655: On1 Concept.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161655
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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