510(k) · Cleared
ClearedHealing Cap Multi-Unit Titanium
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 26, 2017 as substantially equivalent to K925780 (Nobelpharma USA, Inc., 1993) after a 191-day review. Its family tree reaches back 1 generation to 1993. 2 later devices descend from it.
- Decided
- Oct 26, 2017
- Review
- 191 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K925780 (1993). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK925780 Branemark System Healing CapsNobelpharma USA, Inc. · 1993
- This deviceK171142 Healing Cap Multi-Unit TitaniumNobel Biocare AB · 2017
- Descendant · cites it directly · 0 of its ownK241616 ALLONUS Tech ProstheticsAllonus Tech Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK191634 Scan Abutments and Comfort CapsDentium Co., Ltd. · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K925780 | Branemark System Healing Caps | Nobelpharma USA, Inc. | 1993 | — |
| 0 (this device) | K171142 | Healing Cap Multi-Unit Titanium | Nobel Biocare AB | 2017 | — |
| +1 | K241616 | ALLONUS Tech Prosthetics | Allonus Tech Co., Ltd. | 2024 | — |
| +1 | K191634 | Scan Abutments and Comfort Caps | Dentium Co., Ltd. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K925780 | Branemark System Healing CapsSummary page 4…t Abutment (21 CFR 872.3630) Regulatory Class: II Product Code: NHA III. PREDICATE DEVICE Primary Predicate: Nobelpharma Branemark System – Healing Cap (K925780) Reference Predicate: Multi-unit Abutment Plus (K161416) IV. DEVICE DESCRIPTION The Healing Cap Multi-unit Titaniu… | 1993 |
| † | K161416 | Multi-unit Abutment Plus | 2017 |
What descends from it? (2)
2 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 Healing Cap Multi-unit Titanium is a premanufactured prosthetic component to be directly connected to the dental abutment during soft tissue healing to protect the internal connection of the abutments and prepare the soft tissue for the prosthetic procedure. Maximum intra-oral use is 180-days.
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/K171142 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171142: Healing Cap Multi-Unit Titanium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171142
Report an extraction error
Are you the manufacturer?
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