510(k) · Cleared
ClearedHealing Abutments and Cover Screws
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 Jan 23, 2020 as substantially equivalent to K052957 (Dentium Co., Ltd., 2006) after a 139-day review. Its family tree reaches back 2 generations to 1994. 5 later devices descend from it.
- Decided
- Jan 23, 2020
- Review
- 139 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K931767 (1994). 3 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK931767 Astra Tech Implants-Dental SystemAstra Tech, Inc. · 1994
- 1 generation backK052957 Implantium ProstheticsDentium Co., Ltd. · 2006
- This deviceK192436 Healing Abutments and Cover ScrewsDentium Co., Ltd. · 2020
- Descendant · cites it directly · 4 of its ownK210826 Healing Abutment, Cover ScrewMegagen Implant Co., Ltd. · 2022
- Descendant · 2 generations on · 1 of its ownK252585 ZENEX Implant System_R-SystemIzenimplant Co., Ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK253334 ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK230126 Dentis s-Clean Regular AbutmentDentis Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK230203 Dentis I-FIX AbutmentDentis Co., Ltd. · 2023
Most influential descendants
Showing 5 of 5 · See all- K210826Healing Abutment, Cover ScrewMegagen Implant Co., Ltd. · 2022 · cites it directly4descendants
- K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd. · 2026 · 2 generations on1descendant
- K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd. · 2026 · 3 generations on0descendants
- K230126Dentis s-Clean Regular AbutmentDentis Co., Ltd. · 2023 · 2 generations on0descendants
- K230203Dentis I-FIX AbutmentDentis Co., Ltd. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K931767 | Astra Tech Implants-Dental System | Astra Tech, Inc. | 1994 | — |
| −1 | K052957 | Implantium Prosthetics | Dentium Co., Ltd. | 2006 | — |
| 0 (this device) | K192436 | Healing Abutments and Cover Screws | Dentium Co., Ltd. | 2020 | — |
| +1 | K210826 | Healing Abutment, Cover Screw | Megagen Implant Co., Ltd. | 2022 | — |
| +2 | K252585 | ZENEX Implant System_R-System | Izenimplant Co., Ltd. | 2026 | — |
| +3 | K253334 | ZENEX Implant System_Short (R-System) | Izenimplant Co., Ltd. | 2026 | — |
| +2 | K230126 | Dentis s-Clean Regular Abutment | Dentis Co., Ltd. | 2023 | — |
| +2 | K230203 | Dentis I-FIX Abutment | Dentis Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 2 | 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 |
|---|---|---|---|
| * | K052957 | Implantium ProstheticsSummary page 4…ass II Classification Panel : Dental Products Panel Reviewing Branch : Dental Devices Branch 3. Predicate Device Primary Predicate K052957 Implantium Abutments Reference Predicate K041368 Implantium K112045 SimpleLine II Abutment Sys… | 2006 |
| † | K041368 | Dentium CO., LTD. Implantium | 2004 |
| † | K112045 | Simpleline II Abutment System | 2012 |
| † | K141457 | Dentium Implantium and Superline Abutments | 2014 |
| † | K153268 | NR Line Implant System | 2016 |
| † | K172640 | Dentium Implantium & SuperLine Prosthetics | 2018 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210826 | Healing Abutment, Cover Screw | 2022 | 4 |
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 2 companies; a new generation was cleared every 13.5 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K210826 (Megagen Implant Co., Ltd., 2022) has gone furthest, with 4 descendants of its own.
- 9 other devices also cite its predicate K052957.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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/K192436 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192436: Healing Abutments and Cover Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192436
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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