510(k) · Cleared
ClearedAvana Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osstem Co., Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Sep 1, 2005 as substantially equivalent to K003226 (Lifecore Biomedical, Inc., 2001) and 2 other predicates after a 79-day review. Its family tree reaches back 4 generations to 1990. 222 later devices descend from it.
- Decided
- Sep 1, 2005
- Review
- 79 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K894595 (1990). 14 ancestors in all. 222 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 3 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 2 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 1 generation backK011879 3A Dental Implant SystemOsseco Biosource, Ltd. · 2002
- This deviceK051576 Avana Dental Implant SystemOsstem Co., Ltd. · 2005
- Descendant · cites it directly · 211 of its ownK062051 SS SystemOsstem Implant Co., Ltd. · 2006
- Descendant · 2 generations on · 202 of its ownK063861 GS SystemOsstem Implant Co., Ltd. · 2007
- Descendant · cites it directly · 183 of its ownK062030 US SystemOsstem Implant Co., Ltd. · 2006
- Descendant · 2 generations on · 141 of its ownK073247 US/SS/GS SystemOsstem Implant Co., Ltd. · 2008
- Descendant · 2 generations on · 129 of its ownK081575 HU/HS/HG Prosthetic SystemOsstem Implant Co., Ltd. · 2008
Showing 5 of 222 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 222 · See all- K062051SS SystemOsstem Implant Co., Ltd. · 2006 · cites it directly211descendants
- K063861GS SystemOsstem Implant Co., Ltd. · 2007 · 2 generations on202descendants
- K062030US SystemOsstem Implant Co., Ltd. · 2006 · cites it directly183descendants
- K073247US/SS/GS SystemOsstem Implant Co., Ltd. · 2008 · 2 generations on141descendants
- K081575HU/HS/HG Prosthetic SystemOsstem Implant Co., Ltd. · 2008 · 2 generations on129descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −3 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −2 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −1 | K011879 | 3A Dental Implant System | Osseco Biosource, Ltd. | 2002 | — |
| 0 (this device) | K051576 | Avana Dental Implant System | Osstem Co., Ltd. | 2005 | — |
| +1 | K062051 | SS System | Osstem Implant Co., Ltd. | 2006 | — |
| +2 | K063861 | GS System | Osstem Implant Co., Ltd. | 2007 | — |
| +1 | K062030 | US System | Osstem Implant Co., Ltd. | 2006 | — |
| +2 | K073247 | US/SS/GS System | Osstem Implant Co., Ltd. | 2008 | — |
| +2 | K081575 | HU/HS/HG Prosthetic 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 | 2 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K003226 | The Lifecore Stage-1 Single Stage RBM Dental Implant SystemSummary page 1…612-073 CONTACT Mr.;Ki Won Ki PREDICATE Lifecore Stage -i Single Stage RBM Dental Implant System, K- DEVICE 003226 Osstem Co. 3A Dental Implant System, K01 1879 Swissplus Dental Implant, K-0021… | 2001 |
| * | K011879 | 3A Dental Implant SystemSummary page 1…ATE Lifecore Stage -i Single Stage RBM Dental Implant System, K- DEVICE 003226 Osstem Co. 3A Dental Implant System, K01 1879 Swissplus Dental Implant, K-0021 88 _________ DEVICE The Avana SS-Il Implant… | 2002 |
| * | K002188 | Swissplus Implant System, Model SPWB 8,10,12,14/OPH20/SMPR, SPB… | 2000 |
What descends from it? (222)
See all 2224 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 15 years and passes through 5 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K062051 (Osstem Implant Co., Ltd., 2006) has gone furthest, with 211 descendants of its own.
- 4 other devices also cite its predicate K003226.
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?
AVANA Dental Implant Systems are designed for use in dental implant surgery. A successfully osseointegrated implant will achieve a firm and direct connection between the living bone and the surface of the titanium fixture when surgically implanted under controlled conditions, as per well known clinical studies. They are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051576 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051576: Avana Dental 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/K051576
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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