510(k) · Cleared
ClearedScan Abutments and Comfort Caps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentium Co., Ltd. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Nov 4, 2019 as substantially equivalent to K172640 (Dentium Co., Ltd., 2018) and 2 other predicates after a 138-day review. Its family tree reaches back 2 generations to 1993.
- Decided
- Nov 4, 2019
- Review
- 138 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K925780 (1993). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K925780 | Branemark System Healing Caps | Nobelpharma USA, Inc. | 1993 | — |
| −1 | K171142 | Healing Cap Multi-Unit Titanium | Nobel Biocare AB | 2017 | — |
| 0 (this device) | K191634 | Scan Abutments and Comfort Caps | Dentium Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 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? (3)
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 |
|---|---|---|---|
| * | K172640 | Dentium Implantium & SuperLine ProstheticsSummary page 4…cation Panel : Dental Products Panel Reviewing Branch : Dental Devices Branch 3. Predicate Device Primary Predicate for Scan Abutment K172640 Dentium Implantium® & SuperLine® Prosthetics K153268 NR Line Implant System Primary Predicate for Comfort… | 2018 |
| * | K153268 | NR Line Implant SystemSummary page 4…ch : Dental Devices Branch 3. Predicate Device Primary Predicate for Scan Abutment K172640 Dentium Implantium® & SuperLine® Prosthetics K153268 NR Line Implant System Primary Predicate for Comfort Cap K171142 Healing Cap Multi-Unit Titanium 510(… | 2016 |
| * | K171142 | Healing Cap Multi-Unit TitaniumSummary page 4…ate for Scan Abutment K172640 Dentium Implantium® & SuperLine® Prosthetics K153268 NR Line Implant System Primary Predicate for Comfort Cap K171142 Healing Cap Multi-Unit Titanium 510(k) Summary Page… | 2017 |
| † | K173374 | TSV BellaTek Encode Healing Abutments | 2017 |
| † | K172160 | Southern Implants PEEK Abutments | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 3 companies; a new generation was cleared every 24.5 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K172640.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
Dentium Prosthetics are intended for use as an aid in prosthetic rehabilitation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191634 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191634: Scan Abutments and Comfort Caps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191634
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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