510(k) · Cleared
ClearedDentis I-FIX Abutment
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentis Co., Ltd. · NHA Abutment, Implant, Dental, Endosseous
Cleared on May 3, 2023 as substantially equivalent to K210826 (Megagen Implant Co., Ltd., 2022) after a 98-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- May 3, 2023
- Review
- 98 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K931767 (1994). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK931767 Astra Tech Implants-Dental SystemAstra Tech, Inc. · 1994
- 3 generations backK052957 Implantium ProstheticsDentium Co., Ltd. · 2006
- 2 generations backK192436 Healing Abutments and Cover ScrewsDentium Co., Ltd. · 2020
- 1 generation backK210826 Healing Abutment, Cover ScrewMegagen Implant Co., Ltd. · 2022
- This deviceK230203 Dentis I-FIX AbutmentDentis Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K931767 | Astra Tech Implants-Dental System | Astra Tech, Inc. | 1994 | — |
| −3 | K052957 | Implantium Prosthetics | Dentium Co., Ltd. | 2006 | — |
| −2 | K192436 | Healing Abutments and Cover Screws | Dentium Co., Ltd. | 2020 | — |
| −1 | K210826 | Healing Abutment, Cover Screw | Megagen Implant Co., Ltd. | 2022 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K210826 | Healing Abutment, Cover ScrewSummary page 4…s: Class II • Date prepared: 05/03/2023 Predicate Devices: The subject device is substantially equivalent to the following predicate devices: Primary Predicate • K210826, Healing Abutment, Cover Screw manufactured by MegaGen Implant Co., Ltd. Reference devices • K083586, I-FIX SYSTEM manufactur… | 2022 |
| † | K083586 | I-Fix System | 2009 |
| † | K111364 | Haptite Coating Implant System | 2012 |
| † | K171027 | Dentis Dental Implant System | 2017 |
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 29 years and passes through 4 companies; a new generation was cleared every 12.5 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 2 other devices also cite its predicate K210826.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
Dentis I-FIX Abutment is intended for use as an aid in prosthetic rehabilitation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230203 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230203: Dentis I-FIX Abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230203
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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