510(k) · Cleared
Cleared3A Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osseco Biosource, Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Aug 27, 2002 as substantially equivalent to K993595 (Nobel Biocare Uas, Inc., 2000) and 1 other predicate after a 438-day review. Its family tree reaches back 3 generations to 1990. 223 later devices descend from it.
- Decided
- Aug 27, 2002
- Review
- 438 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K894595 (1990). 11 ancestors in all. 223 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 2 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 1 generation backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- This deviceK011879 3A Dental Implant SystemOsseco Biosource, Ltd. · 2002
- Descendant · cites it directly · 222 of its ownK051576 Avana Dental Implant SystemOsstem Co., Ltd. · 2005
- Descendant · 2 generations on · 211 of its ownK062051 SS SystemOsstem Implant Co., Ltd. · 2006
- Descendant · 3 generations on · 202 of its ownK063861 GS SystemOsstem Implant Co., Ltd. · 2007
- Descendant · 2 generations on · 183 of its ownK062030 US SystemOsstem Implant Co., Ltd. · 2006
- Descendant · 3 generations on · 141 of its ownK073247 US/SS/GS SystemOsstem Implant Co., Ltd. · 2008
Showing 5 of 223 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 223 · See all- K051576Avana Dental Implant SystemOsstem Co., Ltd. · 2005 · cites it directly222descendants
- K062051SS SystemOsstem Implant Co., Ltd. · 2006 · 2 generations on211descendants
- K063861GS SystemOsstem Implant Co., Ltd. · 2007 · 3 generations on202descendants
- K062030US SystemOsstem Implant Co., Ltd. · 2006 · 2 generations on183descendants
- K073247US/SS/GS SystemOsstem Implant Co., Ltd. · 2008 · 3 generations on141descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −2 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −1 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| 0 (this device) | K011879 | 3A Dental Implant System | Osseco Biosource, Ltd. | 2002 | — |
| +1 | K051576 | Avana Dental Implant System | Osstem Co., Ltd. | 2005 | — |
| +2 | K062051 | SS System | Osstem Implant Co., Ltd. | 2006 | — |
| +3 | K063861 | GS System | Osstem Implant Co., Ltd. | 2007 | — |
| +2 | K062030 | US System | Osstem Implant Co., Ltd. | 2006 | — |
| +3 | K073247 | US/SS/GS System | Osstem Implant Co., Ltd. | 2008 | — |
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 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 10 | 0 |
| 2009 | 9 | 0 |
| 2010 | 6 | 0 |
| 2011 | 5 | 0 |
| 2012 | 9 | 0 |
| 2013 | 13 | 0 |
| 2014 | 8 | 0 |
| 2015 | 5 | 0 |
| 2016 | 9 | 0 |
| 2017 | 14 | 0 |
| 2018 | 12 | 0 |
| 2019 | 5 | 0 |
| 2020 | 23 | 0 |
| 2021 | 13 | 0 |
| 2022 | 14 | 0 |
| 2023 | 28 | 0 |
| 2024 | 19 | 0 |
| 2025 | 8 | 0 |
| 2026 | 8 | 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 |
|---|---|---|---|
| * | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon Placement)Summary page 2…IT1 Dental Implant Systems Nobel Biocare Implant System K993 595 KO023 74 Indications for Use Design: II Mandible and… | 2000 |
| * | K002374 | Iti Dental Implant System Monotype Implant | 2000 |
What descends from it? (223)
See all 2231 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051576 | Avana Dental Implant System | 2005 | 222 |
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 12 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K051576 (Osstem Co., Ltd., 2005) has gone furthest, with 222 descendants of its own.
- 6 other devices also cite its predicate K993595.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 3A Dental Implant System is intended for single or multiple surgical implantation (with or without tissue integration) in the maxillary and or mandibular arches for the purpose of providing prosthetic support for dental restorations in partially or totally edentulous individuals. May be used for single tooth restoration.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K011879 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011879: 3A Dental 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/K011879
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026