510(k) · Cleared
ClearedSinus Quick EB System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neobiotech Co., Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Aug 28, 2009 as substantially equivalent to K062030 (Osstem Implant Co., Ltd., 2006) and 2 other predicates after a 192-day review. Its family tree reaches back 9 generations to 1995.
- Decided
- Aug 28, 2009
- Review
- 192 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K944964 (1995). 72 ancestors in all, the oldest K874590 (1988). No later device cites it as a predicate yet.
- Root · 9 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 5 generations between
- 3 generations backK050635 Allfim Implant SystemsCowellmedi Co., Ltd. · 2005
- 2 generations backK071148 Atlas Implant SystemCowellmedi Co., Ltd. · 2008
- 1 generation backK090054 Atlas Implant System - Wide PlusCowellmedi Co., Ltd. · 2009
- This deviceK090377 Sinus Quick EB SystemNeobiotech Co., Ltd. · 2009
Show all 9 generations
- Root · 9 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 8 generations backK961728 Miruscone Abutment SystemNobelpharma USA, Inc. · 1996
- 7 generations backK962403 Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
- 6 generations backK971706 Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997
- 5 generations backK974150 Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · Recalled
- 4 generations backK041655 Bio Plant System (Implants and Abutments)Cowellmedi Co., Ltd. · 2004
- 3 generations backK050635 Allfim Implant SystemsCowellmedi Co., Ltd. · 2005
- 2 generations backK071148 Atlas Implant SystemCowellmedi Co., Ltd. · 2008
- 1 generation backK090054 Atlas Implant System - Wide PlusCowellmedi Co., Ltd. · 2009
- This deviceK090377 Sinus Quick EB SystemNeobiotech Co., Ltd. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K944964 | Branemark System Miruscone Abutment System | Nobelpharma USA, Inc. | 1995 | — |
| −8 | K961728 | Miruscone Abutment System | Nobelpharma USA, Inc. | 1996 | — |
| −7 | K962403 | Noblepharma Wide Accessories | Nobelpharma USA, Inc. | 1996 | — |
| −6 | K971706 | Tiadapt Abutment System | Nobel Biocare Uas, Inc. | 1997 | — |
| −5 | K974150 | Procera Preparable Abutment System | Nobel Biocare Uas, Inc. | 1998 | 2 |
| −4 | K041655 | Bio Plant System (Implants and Abutments) | Cowellmedi Co., Ltd. | 2004 | — |
| −3 | K050635 | Allfim Implant Systems | Cowellmedi Co., Ltd. | 2005 | — |
| −2 | K071148 | Atlas Implant System | Cowellmedi Co., Ltd. | 2008 | — |
| −1 | K090054 | Atlas Implant System - Wide Plus | Cowellmedi Co., Ltd. | 2009 | — |
| 0 (this device) | K090377 | Sinus Quick EB System | Neobiotech Co., Ltd. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 10 | 0 |
| 1994 | 5 | 0 |
| 1995 | 5 | 0 |
| 1996 | 5 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 6 | 0 |
| 2001 | 3 | 0 |
| 2002 | 6 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 2 | 0 |
| 2008 | 4 | 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 |
|---|---|---|---|
| * | K062030 | US SystemSummary page 2…per ASTM and ISO standards. Predicate Devices: The subject device is substantially equivalent to the following predicate devices: · US System (Osstem Co., Ltd.; K062030) * DIO Dental Implant System (DIO Corp.; K070570) * Atlas Implant System - Wide Plus (Cowellmedi Co., Ltd.; K090054)… | 2006 |
| * | K070570 | Dio Implant SystemSummary page 2…ubject device is substantially equivalent to the following predicate devices: · US System (Osstem Co., Ltd.; K062030) * DIO Dental Implant System (DIO Corp.; K070570) * Atlas Implant System - Wide Plus (Cowellmedi Co., Ltd.; K090054) Comparison to Predicate Devices: Testing and other c… | 2008 |
| * | K090054 | Atlas Implant System - Wide Plus Cleared while this submission was under review Summary page 2…ces: · US System (Osstem Co., Ltd.; K062030) * DIO Dental Implant System (DIO Corp.; K070570) * Atlas Implant System - Wide Plus (Cowellmedi Co., Ltd.; K090054) Comparison to Predicate Devices: Testing and other comparisons have established that the subject of SQ EB System is substanti… | 2009 |
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 14 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 5 of the 72 ancestors have a recall of any class.
- 9 other devices also cite its predicate K062030.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 SQ EB 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. Smaller (e 3.5, e 4.0, o 5.0) implants are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger (e 6.0, e 7.0, e 8.0) implants are dedicated for the molar region and not indicated for immediate loading.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090377 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090377: Sinus Quick EB System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090377
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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