510(k) · Cleared
ClearedHIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hiossen, Inc. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Jan 8, 2025 as substantially equivalent to K123627 (Hiossen, Inc., 2013) after a 271-day review. Its family tree reaches back 12 generations to 1990.
- Decided
- Jan 8, 2025
- Review
- 271 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K894595 (1990). 29 ancestors in all. No later device cites it as a predicate yet.
- Root · 12 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 8 generations between
- 3 generations backK100245 HS/HG Prosthetic SystemOsstem Implant Co., Ltd. · 2010
- 2 generations backK110308 Prosthetic SystemOsstem Implant Co., Ltd. · 2011
- 1 generation backK123627 ET Smartfit AbutmentHiossen, Inc. · 2013
- This deviceK241003 HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled…Hiossen, Inc. · 2025
Show all 12 generations
- Root · 12 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 11 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 10 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 9 generations backK011879 3A Dental Implant SystemOsseco Biosource, Ltd. · 2002
- 8 generations backK051576 Avana Dental Implant SystemOsstem Co., Ltd. · 2005
- 7 generations backK062051 SS SystemOsstem Implant Co., Ltd. · 2006
- 6 generations backK063861 GS SystemOsstem Implant Co., Ltd. · 2007
- 5 generations backK073247 US/SS/GS SystemOsstem Implant Co., Ltd. · 2008
- 4 generations backK081575 HU/HS/HG Prosthetic SystemOsstem Implant Co., Ltd. · 2008
- 3 generations backK100245 HS/HG Prosthetic SystemOsstem Implant Co., Ltd. · 2010
- 2 generations backK110308 Prosthetic SystemOsstem Implant Co., Ltd. · 2011
- 1 generation backK123627 ET Smartfit AbutmentHiossen, Inc. · 2013
- This deviceK241003 HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled…Hiossen, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −11 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −10 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −9 | K011879 | 3A Dental Implant System | Osseco Biosource, Ltd. | 2002 | — |
| −8 | K051576 | Avana Dental Implant System | Osstem Co., Ltd. | 2005 | — |
| −7 | K062051 | SS System | Osstem Implant Co., Ltd. | 2006 | — |
| −6 | K063861 | GS System | Osstem Implant Co., Ltd. | 2007 | — |
| −5 | K073247 | US/SS/GS System | Osstem Implant Co., Ltd. | 2008 | — |
| −4 | K081575 | HU/HS/HG Prosthetic System | Osstem Implant Co., Ltd. | 2008 | — |
| −3 | K100245 | HS/HG Prosthetic System | Osstem Implant Co., Ltd. | 2010 | — |
| −2 | K110308 | Prosthetic System | Osstem Implant Co., Ltd. | 2011 | — |
| −1 | K123627 | ET Smartfit Abutment | Hiossen, Inc. | 2013 | — |
| 0 (this device) | K241003 | HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment) | Hiossen, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 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 |
|---|---|---|---|
| * | K123627 | ET Smartfit AbutmentSummary page 5…ation Number: 21 CFR 872.3630 Review Panel: Dental Device Class: Class II Product Code: NHA Predicate Device: ET SMARTFit Abutment (K123627) Reference Device: Warantec Custom Abutment (K221972) HIOSSEN Implant System (K140934)… | 2013 |
| † | K221972 | Warantec Custom Abutment | 2023 |
| † | K140934 | Hiossen Implant System | 2014 |
| † | K151626 | ET III Bio-SA Fixture System | 2016 |
| † | K153332 | ETIII SA Fixture System (O3.2mm) | 2016 |
| † | K183242 | ET IV SA Dental Implants | 2019 |
| † | K203360 | EK Implants and Abutments System | 2022 |
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 35 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- 1 of the 29 ancestors has a recall of any class.
- 2 other devices also cite its predicate K123627.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 HIOSSEN Pre-milled Abutments are intended for use with HIOSSEN dental implants to provide support for prosthetic restorations such as crowns, bridges or overdentures. All digitally designed CAD/CAM customizations for the HIOSSSEN Pre-milled Abutments are intended to be sent to a HIOSSEN validated milling facility. ET HIOSSEN Pre-milled Abutments are compatible with the following devices: 1. ETIII & ETII SA Dental Implants (Mini, Regular, (Ultra-wide…
Read the full statement (174 words)
The HIOSSEN Pre-milled Abutments are intended for use with HIOSSEN dental implants to provide support for prosthetic restorations such as crowns, bridges or overdentures.
All digitally designed CAD/CAM customizations for the HIOSSSEN Pre-milled Abutments are intended to be sent to a HIOSSEN validated milling facility.
ET HIOSSEN Pre-milled Abutments are compatible with the following devices:
1. ETIII & ETII SA Dental Implants (Mini, Regular, (Ultra-wide Regular) - K140934
/ Implant Diameter (mm):3.5, 3.75, 3.77, 4.2, 4.25, 4.45, 4.6, 4.25, 4.63, 4.65, 4.9, 5.0, 5.05, 5.08, 5.1, 5.92, 5.95, 6, 6.8
2. ETIII NH Dental Implants (Mini & Regular, Ultra-wide Regular) - K151626
/Implant Diameter (mm): 3.77, 3.75, 4.25, 4.6 4.65, 4.63, 5.05, 5.08, 5.10
3. ETIII SA D3.2 Dental Implants (Mini) - K153332
/Implant Diameter (mm): 3.2
4. ET IV SA Dental Implants (Regular & Ultra-wide)- K183242
/Implant Diameter (mm):4.4, 4.8, 5.25, 6.2 & 7.1
EK HIOSSEN Pre-milled Abutments are compatible with the following devices:
1. EKIII SA Dental Implant (Mini) & EKIII NH Dental Implants (Mini) - K203360
/Implant Diameter (mm):3.5 ~ 5.5
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241003 · printed Nov 5, 2026
Cite this page
510(k) Report. “K241003: HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K241003
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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