510(k) · Cleared
ClearedUniversal Base 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 Oct 31, 2018 as substantially equivalent to K031719 (Nobel Biocare AB, 2003) after a 208-day review. Its family tree reaches back 2 generations to 1994. 9 later devices descend from it.
- Decided
- Oct 31, 2018
- Review
- 208 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K913255 (1994). 9 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK913255 Ceramic (TM) AbutmentCeramic Core Corp. · 1994
- 1 generation backK031719 Esthetic Zirconia AbutmentNobel Biocare AB · 2003
- This deviceK180899 Universal Base AbutmentNobel Biocare AB · 2018
- Descendant · cites it directly · 3 of its ownK193084 TIB Abutment SystemSouthern Implants (Pty), Ltd. · 2020
- Descendant · cites it directly · 3 of its ownK200040 Universal Base Conical Connection (CC)Nobel Biocare AG · 2020
- Descendant · 2 generations on · 2 of its ownK211109 N1 TiUltra TCC Implant SystemNobel Biocare Services AG · 2021 · Recalled
- Descendant · 3 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
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K193084TIB Abutment SystemSouthern Implants (Pty), Ltd. · 2020 · cites it directly3descendants
- K200040Universal Base Conical Connection (CC)Nobel Biocare AG · 2020 · cites it directly3descendants
- K211109N1 TiUltra TCC Implant SystemNobel Biocare Services AG · 2021 · 2 generations on2descendants
- K220048NobelProcera Zirconia N1 BaseNobel Biocare Services AG · 2022 · 3 generations on1descendant
- K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC…Nobel 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 | K913255 | Ceramic (TM) Abutment | Ceramic Core Corp. | 1994 | — |
| −1 | K031719 | Esthetic Zirconia Abutment | Nobel Biocare AB | 2003 | — |
| 0 (this device) | K180899 | Universal Base Abutment | Nobel Biocare AB | 2018 | — |
| +1 | K193084 | TIB Abutment System | Southern Implants (Pty), Ltd. | 2020 | — |
| +1 | K200040 | Universal Base Conical Connection (CC) | Nobel Biocare AG | 2020 | — |
| +2 | K211109 | N1 TiUltra TCC Implant System | Nobel Biocare Services AG | 2021 | 2 |
| +3 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2026 | 1 | 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 |
|---|---|---|---|
| * | K031719 | Esthetic Zirconia AbutmentSummary 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 K031719, Nobel Biocare - Esthetic Zirconia Abutment Reference Devices K153645, Vita Zahnfabrik H. Rauter GmbH Co – Vita Enamic® Implant… | 2003 |
| † | 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? (9)
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 24 years and passes through 2 companies; a new generation was cleared every 15.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K193084 (Southern Implants (Pty), Ltd., 2020) has gone furthest, with 3 descendants of its own.
- 8 other devices also cite its predicate K031719.
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 Universal Base Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. The Universal Base Abutments consist of two major parts. Specifically, the titanium base and mesostructure components make up a two-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 as stated in the FDA summary.
https://510kreport.com/device/K180899 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180899: Universal Base Abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180899
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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