510(k) · Cleared
ClearedCotec Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cotec Implant Co., Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Jul 9, 2010 as substantially equivalent to K090825 (Neobiotech Co., Ltd., 2009) and 1 other predicate after a 137-day review. Its family tree reaches back 9 generations to 1990.
- Decided
- Jul 9, 2010
- Review
- 137 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K894595 (1990). 26 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 5 generations between
- 3 generations backK063861 GS SystemOsstem Implant Co., Ltd. · 2007
- 2 generations backK073465 US/GS Ultra Wide SystemOsstem Implant Co., Ltd. · 2008
- 1 generation backK090825 SQ IS SystemNeobiotech Co., Ltd. · 2009
- This deviceK100511 Cotec Dental Implant SystemCotec Implant Co., Ltd. · 2010
Show all 9 generations
- Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 8 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 7 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 6 generations backK011879 3A Dental Implant SystemOsseco Biosource, Ltd. · 2002
- 5 generations backK051576 Avana Dental Implant SystemOsstem Co., Ltd. · 2005
- 4 generations backK062051 SS SystemOsstem Implant Co., Ltd. · 2006
- 3 generations backK063861 GS SystemOsstem Implant Co., Ltd. · 2007
- 2 generations backK073465 US/GS Ultra Wide SystemOsstem Implant Co., Ltd. · 2008
- 1 generation backK090825 SQ IS SystemNeobiotech Co., Ltd. · 2009
- This deviceK100511 Cotec Dental Implant SystemCotec Implant Co., Ltd. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −8 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −7 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −6 | K011879 | 3A Dental Implant System | Osseco Biosource, Ltd. | 2002 | — |
| −5 | K051576 | Avana Dental Implant System | Osstem Co., Ltd. | 2005 | — |
| −4 | K062051 | SS System | Osstem Implant Co., Ltd. | 2006 | — |
| −3 | K063861 | GS System | Osstem Implant Co., Ltd. | 2007 | — |
| −2 | K073465 | US/GS Ultra Wide System | Osstem Implant Co., Ltd. | 2008 | — |
| −1 | K090825 | SQ IS System | Neobiotech Co., Ltd. | 2009 | — |
| 0 (this device) | K100511 | Cotec Dental Implant System | Cotec Implant Co., Ltd. | 2010 | — |
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 |
| 2009 | 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? (2)
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 |
|---|---|---|---|
| * | K090825 | SQ IS SystemSummary page 2…Predicate Devices & Comparison The subject device is substantially equivalent to the following predicate devices: * SQ IS System (Neobiotech Co., Ltd.; K090825) * SQ IT System (Neobiotech Co., Ltd.; K(090527) Testing and other comparisons have established that the subject… | 2009 |
| * | K090527 | Sinus Quick IT SystemSummary page 2…Subject Device Predicate Device 5 10(K) Number N /A K090825 K090527 Device Name Cotec Dental Implant System SQ IS System SQ IT System Manufactu… | 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 20 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 26 ancestors has a recall of any class.
- 4 other devices also cite its predicate K090825.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Cotec Dental 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. This system is not intended for immediate loading.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100511 · printed Nov 3, 2026
Cite this page
510(k) Report. “K100511: Cotec Dental Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K100511
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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