510(k) · Cleared
ClearedET Smartfit 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 Jun 28, 2013 as substantially equivalent to K110308 (Osstem Implant Co., Ltd., 2011) after a 217-day review. Its family tree reaches back 11 generations to 1990. 21 later devices descend from it.
- Decided
- Jun 28, 2013
- Review
- 217 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K894595 (1990). 28 ancestors in all. 21 later devices descend from it, 3 citing it directly.
- Root · 11 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 7 generations between
- 3 generations backK081575 HU/HS/HG Prosthetic SystemOsstem Implant Co., Ltd. · 2008
- 2 generations backK100245 HS/HG Prosthetic SystemOsstem Implant Co., Ltd. · 2010
- 1 generation backK110308 Prosthetic SystemOsstem Implant Co., Ltd. · 2011
- This deviceK123627 ET Smartfit AbutmentHiossen, Inc. · 2013
- Descendant · cites it directly · 18 of its ownK152559 TruAbutment DSTruabutment · 2016
- Descendant · 2 generations on · 17 of its ownK170259 TruAbutment DSTruabutment · 2017
- Descendant · 3 generations on · 8 of its ownK172304 TruAbutment DSTruabutment, Inc. · 2018
- Descendant · 4 generations on · 7 of its ownK183106 TruAbutment DSTruabutment, Inc. · 2020
- Descendant · 3 generations on · 6 of its ownK201197 TruAbutment DS, TruBase STruabutment, Inc. · 2021
Show all 11 generations
- Root · 11 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 10 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 9 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 8 generations backK011879 3A Dental Implant SystemOsseco Biosource, Ltd. · 2002
- 7 generations backK051576 Avana Dental Implant SystemOsstem Co., Ltd. · 2005
- 6 generations backK062051 SS SystemOsstem Implant Co., Ltd. · 2006
- 5 generations backK063861 GS SystemOsstem Implant Co., Ltd. · 2007
- 4 generations backK073247 US/SS/GS SystemOsstem Implant Co., Ltd. · 2008
- 3 generations backK081575 HU/HS/HG Prosthetic SystemOsstem Implant Co., Ltd. · 2008
- 2 generations backK100245 HS/HG Prosthetic SystemOsstem Implant Co., Ltd. · 2010
- 1 generation backK110308 Prosthetic SystemOsstem Implant Co., Ltd. · 2011
- This deviceK123627 ET Smartfit AbutmentHiossen, Inc. · 2013
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K152559TruAbutment DSTruabutment · 2016 · cites it directly18descendants
- K170259TruAbutment DSTruabutment · 2017 · 2 generations on17descendants
- K172304TruAbutment DSTruabutment, Inc. · 2018 · 3 generations on8descendants
- K183106TruAbutment DSTruabutment, Inc. · 2020 · 4 generations on7descendants
- K201197TruAbutment DS, TruBase STruabutment, Inc. · 2021 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −10 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −9 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −8 | K011879 | 3A Dental Implant System | Osseco Biosource, Ltd. | 2002 | — |
| −7 | K051576 | Avana Dental Implant System | Osstem Co., Ltd. | 2005 | — |
| −6 | K062051 | SS System | Osstem Implant Co., Ltd. | 2006 | — |
| −5 | K063861 | GS System | Osstem Implant Co., Ltd. | 2007 | — |
| −4 | K073247 | US/SS/GS System | Osstem Implant Co., Ltd. | 2008 | — |
| −3 | K081575 | HU/HS/HG Prosthetic System | Osstem Implant Co., Ltd. | 2008 | — |
| −2 | K100245 | HS/HG Prosthetic System | Osstem Implant Co., Ltd. | 2010 | — |
| −1 | K110308 | Prosthetic System | Osstem Implant Co., Ltd. | 2011 | — |
| 0 (this device) | K123627 | ET Smartfit Abutment | Hiossen, Inc. | 2013 | — |
| +1 | K152559 | TruAbutment DS | Truabutment | 2016 | — |
| +2 | K170259 | TruAbutment DS | Truabutment | 2017 | — |
| +3 | K172304 | TruAbutment DS | Truabutment, Inc. | 2018 | — |
| +4 | K183106 | TruAbutment DS | Truabutment, Inc. | 2020 | — |
| +3 | K201197 | TruAbutment DS, TruBase S | Truabutment, Inc. | 2021 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 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 |
|---|---|---|---|
| * | K110308 | Prosthetic SystemSummary page 1…artFit Abutment Common or usual name : Dental Device . Classification Name : _ Abutment, implant, dental, endosseous 21CFR872.3630 Class I NHA 3. Predicate Device : : K 110308, The Prosthetic System, Osstem Implant Co., Ltd. 4. Description : A 1) The ET SmartFit Abutment is device made of titanium alloy… | 2011 |
| † | K101096 | HT Iii SA Fixture System | 2010 |
What descends from it? (21)
See all 213 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?
- The line of descent spans 23 years and passes through 7 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 28 ancestors has a recall of any class.
- Of its descendants, K152559 (Truabutment, 2016) has gone furthest, with 18 descendants of its own.
- 6 other devices also cite its predicate K110308.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
ET SMARTfit Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
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/K123627 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123627: ET Smartfit Abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123627
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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