510(k) · Cleared
ClearedSD 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 Feb 24, 2025 as substantially equivalent to K213506 (Arum Dentistry Co., Ltd., 2022) after a 256-day review. Its family tree reaches back 12 generations to 1990.
- Decided
- Feb 24, 2025
- Review
- 256 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K894595 (1990). 28 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 backK113554 Cmi Implant IS SystemNeobiotech Co., Ltd. · 2012
- 2 generations backK181138 IS-III active SystemNeobiotech Co., Ltd. · 2018
- 1 generation backK213506 NB 1 SA Implant SystemArum Dentistry Co., Ltd. · 2022
- This deviceK241703 SD Implant SystemArum Dentistry Co., Ltd. · 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 backK073465 US/GS Ultra Wide SystemOsstem Implant Co., Ltd. · 2008
- 4 generations backK090825 SQ IS SystemNeobiotech Co., Ltd. · 2009
- 3 generations backK113554 Cmi Implant IS SystemNeobiotech Co., Ltd. · 2012
- 2 generations backK181138 IS-III active SystemNeobiotech Co., Ltd. · 2018
- 1 generation backK213506 NB 1 SA Implant SystemArum Dentistry Co., Ltd. · 2022
- This deviceK241703 SD Implant SystemArum Dentistry Co., Ltd. · 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 | K073465 | US/GS Ultra Wide System | Osstem Implant Co., Ltd. | 2008 | — |
| −4 | K090825 | SQ IS System | Neobiotech Co., Ltd. | 2009 | — |
| −3 | K113554 | Cmi Implant IS System | Neobiotech Co., Ltd. | 2012 | — |
| −2 | K181138 | IS-III active System | Neobiotech Co., Ltd. | 2018 | — |
| −1 | K213506 | NB 1 SA Implant System | Arum Dentistry Co., Ltd. | 2022 | — |
| 0 (this device) | K241703 | SD Implant System | Arum Dentistry Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 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 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? (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 |
|---|---|---|---|
| * | K213506 | NB 1 SA Implant SystemSummary page 5…lass II • Date Prepared: 02/24/2025 Predicate Devices The subject device is substantially equivalent to the following predicate devices: Primary Predicate • K213506, NB 1 SA Implant System by Arumdentistry Co., Ltd. Reference Device • K230725, NB Implant System by Arumdentistry Co., Ltd.… | 2022 |
| † | K230725 | NB Implant System | 2023 |
| † | K232560 | Angled Abutment | 2023 |
| † | K223634 | Customized Abutment | 2023 |
| † | K240091 | NB Mini Implant System | 2024 |
| † | K240603 | Ti-Base & Master Fix | 2024 |
| † | K161416 | Multi-unit Abutment Plus | 2017 |
| † | K211090 | ZENEX Implant System | 2022 |
| † | K231753 | Oneday Implant Abutment | 2024 |
| † | K233450 | MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary… | 2024 |
| † | K232268 | STERI-OSS Implant System | 2024 |
| † | K190837 | Internal Hex Implant System | 2020 |
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 2.7 years on median.
- 1 of the 28 ancestors has a recall of any class.
- 4 other devices also cite its predicate K213506.
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 Implant System is indicated for use in partially or fully edentulous mandibular and maxillary areas, in support of single or multiple unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. SD Implant System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load.…
Read the full statement (162 words)
The SD Implant System is indicated for use in partially or fully edentulous mandibular and maxillary areas, in support of single or multiple unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. SD Implant System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5mm are indicated for molar regions. The multi-unit abutments are designed for use in multi-unit restorations. They should be used in cases where multiple implants are placed to support a prosthetic dental restoration not suitable for single-unit restorations. All digitally designed abutments for use with Customized Abutment are intended to be manufactured at an ARUM DENTISTRY validated milling center. Smaller diameter implant bodies (i.e., 3.3mm and 3.7mm) are indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241703 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241703: SD 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/K241703
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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