510(k) · Cleared
ClearedNB 1 SA 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 Apr 6, 2022 as substantially equivalent to K181138 (Neobiotech Co., Ltd., 2018) after a 156-day review. Its family tree reaches back 11 generations to 1990. 5 later devices descend from it.
- Decided
- Apr 6, 2022
- Review
- 156 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K894595 (1990). 27 ancestors in all. 5 later devices descend from it, 5 citing it directly.
- Root · 11 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 7 generations between
- 3 generations backK090825 SQ IS SystemNeobiotech Co., Ltd. · 2009
- 2 generations backK113554 Cmi Implant IS SystemNeobiotech Co., Ltd. · 2012
- 1 generation backK181138 IS-III active SystemNeobiotech Co., Ltd. · 2018
- This deviceK213506 NB 1 SA Implant SystemArum Dentistry Co., Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK230725 NB Implant SystemArum Dentistry Co., Ltd. · 2023
- Descendant · cites it directly · 1 of its ownK222131 NB 1 SA Implant SystemArum Dentistry Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK250280 SD TL Implant SystemArum Dentistry Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK241703 SD Implant SystemArum Dentistry Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK240091 NB Mini Implant SystemArum Dentistry Co., Ltd. · 2024
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 backK073465 US/GS Ultra Wide SystemOsstem Implant Co., Ltd. · 2008
- 3 generations backK090825 SQ IS SystemNeobiotech Co., Ltd. · 2009
- 2 generations backK113554 Cmi Implant IS SystemNeobiotech Co., Ltd. · 2012
- 1 generation backK181138 IS-III active SystemNeobiotech Co., Ltd. · 2018
- This deviceK213506 NB 1 SA Implant SystemArum Dentistry Co., Ltd. · 2022
Most influential descendants
Showing 5 of 5 · See all- K230725NB Implant SystemArum Dentistry Co., Ltd. · 2023 · cites it directly1descendant
- K222131NB 1 SA Implant SystemArum Dentistry Co., Ltd. · 2022 · cites it directly1descendant
- K250280SD TL Implant SystemArum Dentistry Co., Ltd. · 2025 · cites it directly0descendants
- K241703SD Implant SystemArum Dentistry Co., Ltd. · 2025 · cites it directly0descendants
- K240091NB Mini Implant SystemArum Dentistry Co., Ltd. · 2024 · cites it directly0descendants
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 | K073465 | US/GS Ultra Wide System | Osstem Implant Co., Ltd. | 2008 | — |
| −3 | K090825 | SQ IS System | Neobiotech Co., Ltd. | 2009 | — |
| −2 | K113554 | Cmi Implant IS System | Neobiotech Co., Ltd. | 2012 | — |
| −1 | K181138 | IS-III active System | Neobiotech Co., Ltd. | 2018 | — |
| 0 (this device) | K213506 | NB 1 SA Implant System | Arum Dentistry Co., Ltd. | 2022 | — |
| +1 | K230725 | NB Implant System | Arum Dentistry Co., Ltd. | 2023 | — |
| +1 | K222131 | NB 1 SA Implant System | Arum Dentistry Co., Ltd. | 2022 | — |
| +1 | K250280 | SD TL Implant System | Arum Dentistry Co., Ltd. | 2025 | — |
| +1 | K241703 | SD Implant System | Arum Dentistry Co., Ltd. | 2025 | — |
| +1 | K240091 | NB Mini Implant System | Arum Dentistry Co., Ltd. | 2024 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K181138 | IS-III active SystemSummary page 4…: Class II • Date Prepared: 04/06/2022 Predicate Devices: The subject device is substantially equivalent to the following predicate devices: Primary Predicate • K181138, IS-III active System by Neobiotech Co., Ltd. Reference Device • K150060, J2A Dental Implant System manufactured by KJ Medite… | 2018 |
| † | K150060 | J2A Dental Implant System, J2C Dental Implant System | 2015 |
| † | K172100 | URIS OMNI System | 2018 |
| † | K193425 | Pre-Milled Blank | 2020 |
What descends from it? (5)
5 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 32 years and passes through 8 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 27 ancestors has a recall of any class.
- Of its descendants, K230725 (Arum Dentistry Co., Ltd., 2023) has gone furthest, with 1 descendant of its own.
- 10 other devices also cite its predicate K181138.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 NB 1 SA 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. NB 1 SA 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.
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/K213506 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213506: NB 1 SA Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213506
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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