510(k) · Cleared
ClearedSD TL Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arum Dentistry Co., Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Jul 23, 2025 as substantially equivalent to K242753 (Arum Dentistry Co., Ltd., 2025) and 2 other predicates after a 173-day review. Its family tree reaches back 15 generations to 1990.
- Decided
- Jul 23, 2025
- Review
- 173 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 15 generations to K894595 (1990). 69 ancestors in all. No later device cites it as a predicate yet.
- Root · 15 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 11 generations between
- 3 generations backK121995 TS Fixture SystemOsstem Implant Co., Ltd. · 2012
- 2 generations backK222778 Osstem Implant SystemOsstem Implant Co., Ltd. · 2023
- 1 generation backK242753 SD TL Implant SystemArum Dentistry Co., Ltd. · 2025
- This deviceK250280 SD TL Implant SystemArum Dentistry Co., Ltd. · 2025
Show all 15 generations
- Root · 15 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 14 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 13 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 12 generations backK011879 3A Dental Implant SystemOsseco Biosource, Ltd. · 2002
- 11 generations backK051576 Avana Dental Implant SystemOsstem Co., Ltd. · 2005
- 10 generations backK062051 SS SystemOsstem Implant Co., Ltd. · 2006
- 9 generations backK063861 GS SystemOsstem Implant Co., Ltd. · 2007
- 8 generations backK080744 HG II Fixture SystemOsstem Implant Co., Ltd. · 2008
- 7 generations backK082213 GS Iii Fixture SystemOsstem Implant Co., Ltd. · 2008
- 6 generations backK093352 HG Iii Fixture SystemHiossen, Inc. · 2009
- 5 generations backK101096 HT Iii SA Fixture SystemHiossen, Inc. · 2010
- 4 generations backK103537 ET Iii SA Ultra Wide SystemHiossen, Inc. · 2011
- 3 generations backK121995 TS Fixture SystemOsstem Implant Co., Ltd. · 2012
- 2 generations backK222778 Osstem Implant SystemOsstem Implant Co., Ltd. · 2023
- 1 generation backK242753 SD TL Implant SystemArum Dentistry Co., Ltd. · 2025
- This deviceK250280 SD TL Implant SystemArum Dentistry Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −14 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −13 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −12 | K011879 | 3A Dental Implant System | Osseco Biosource, Ltd. | 2002 | — |
| −11 | K051576 | Avana Dental Implant System | Osstem Co., Ltd. | 2005 | — |
| −10 | K062051 | SS System | Osstem Implant Co., Ltd. | 2006 | — |
| −9 | K063861 | GS System | Osstem Implant Co., Ltd. | 2007 | — |
| −8 | K080744 | HG II Fixture System | Osstem Implant Co., Ltd. | 2008 | — |
| −7 | K082213 | GS Iii Fixture System | Osstem Implant Co., Ltd. | 2008 | — |
| −6 | K093352 | HG Iii Fixture System | Hiossen, Inc. | 2009 | — |
| −5 | K101096 | HT Iii SA Fixture System | Hiossen, Inc. | 2010 | — |
| −4 | K103537 | ET Iii SA Ultra Wide System | Hiossen, Inc. | 2011 | — |
| −3 | K121995 | TS Fixture System | Osstem Implant Co., Ltd. | 2012 | — |
| −2 | K222778 | Osstem Implant System | Osstem Implant Co., Ltd. | 2023 | — |
| −1 | K242753 | SD TL Implant System | Arum Dentistry Co., Ltd. | 2025 | — |
| 0 (this device) | K250280 | SD TL Implant System | Arum Dentistry Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2007 | 2 | 0 |
| 2008 | 6 | 0 |
| 2009 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 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 DZE? 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 DZE device
- #1 K211090 ZENEX Implant Systemscore 25.4 · 15 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 |
|---|---|---|---|
| * | K242753 | SD TL Implant SystemSummary page 5…Class II • Date Prepared: 07/23/2025 Predicate Devices The subject device is substantially equivalent to the following predicate devices: Primary Predicate • K242753, SD TL Implant System by Arumdentistry Co., Ltd. Reference Device • K193425, Pre-Milled Blank by Arumdentistry Co., Ltd.… | 2025 |
| * | K213506 | NB 1 SA Implant SystemSummary page 5…s: Primary Predicate • K242753, SD TL Implant System by Arumdentistry Co., Ltd. Reference Device • K193425, Pre-Milled Blank by Arumdentistry Co., Ltd. • K213506, NB 1 SA Implant System by Arumdentistry Co., Ltd. • K241703, SD Implant Abutment by Arumdentistry Co., Ltd. • K240091,… | 2022 |
| * | K212702 | IM/ST Fixture SystemSummary page 5…ant Abutment by Arumdentistry Co., Ltd. • K240091, NB Mini Implant System by Arumdentistry Co., Ltd. • K212517, Magicore System by InnoBioSurg Co., Ltd. • K212702, IM/ST Fixture System by Guilin FiTeeth Medical Instrument Co., Ltd. • K231753, Oneday Implant Abutment by Oneday Biotech Co… | 2022 |
| † | K193425 | Pre-Milled Blank | 2020 |
| † | K241703 | SD Implant System | 2025 |
| † | K240091 | NB Mini Implant System | 2024 |
| † | K212517 | Magicore System | 2021 |
| † | K231753 | Oneday Implant Abutment | 2024 |
| † | K233450 | MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary… | 2024 |
| † | K240603 | Ti-Base & Master Fix | 2024 |
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 8 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 69 ancestors have a recall of any class.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · DZE
31in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZE
184in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZE
465,788in 2025
MAUDE reports naming product code DZE, 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 | 43 | 107 | 11 | 225 |
| 2008 | 61 | 118 | 4 | 393 |
| 2009 | 41 | 110 | 3 | 164 |
| 2010 | 34 | 162 | 3 | 360 |
| 2011 | 26 | 194 | 0 | 362 |
| 2012 | 39 | 174 | 11 | 358 |
| 2013 | 42 | 195 | 1 | 391 |
| 2014 | 36 | 265 | 7 | 1,124 |
| 2015 | 36 | 215 | 3 | 2,894 |
| 2016 | 40 | 219 | 15 | 1,116 |
| 2017 | 48 | 223 | 4 | 9,719 |
| 2018 | 41 | 200 | 4 | 12,892 |
| 2019 | 31 | 231 | 8 | 167,016 |
| 2020 | 41 | 230 | 0 | 255,524 |
| 2021 | 34 | 182 | 6 | 479,618 |
| 2022 | 34 | 243 | 0 | 483,224 |
| 2023 | 35 | 248 | 0 | 537,585 |
| 2024 | 40 | 222 | 1 | 473,629 |
| 2025 | 31 | 184 | 1 | 465,788 |
| 2026 | 15 | 194 | 2 | — |
What is it indicated for?
The SD TL Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. Abutments are indicated for screw-retained single restorations or cement-retained single of multi-unit restorations. SD TL Implant System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. All digitally-designed abutments are intended to be sent to an ARUM DENTISTRY validated milling center for manufacture.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250280 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250280: SD TL Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250280
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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