510(k) · Cleared
ClearedUS System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osstem Implant Co., Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Nov 2, 2006 as substantially equivalent to K051576 (Osstem Co., Ltd., 2005) after a 107-day review. Its family tree reaches back 5 generations to 1990. 183 later devices descend from it.
- Decided
- Nov 2, 2006
- Review
- 107 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K894595 (1990). 15 ancestors in all. 183 later devices descend from it, 10 citing it directly.
- Root · 5 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 4 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 3 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 2 generations backK011879 3A Dental Implant SystemOsseco Biosource, Ltd. · 2002
- 1 generation backK051576 Avana Dental Implant SystemOsstem Co., Ltd. · 2005
- This deviceK062030 US SystemOsstem Implant Co., Ltd. · 2006
- Descendant · cites it directly · 141 of its ownK073247 US/SS/GS SystemOsstem Implant Co., Ltd. · 2008
- Descendant · cites it directly · 129 of its ownK081575 HU/HS/HG Prosthetic SystemOsstem Implant Co., Ltd. · 2008
- Descendant · 2 generations on · 123 of its ownK081786 Ziocera & Convertible SystemOsstem Implant Co., Ltd. · 2008
- Descendant · 2 generations on · 111 of its ownK100245 HS/HG Prosthetic SystemOsstem Implant Co., Ltd. · 2010
- Descendant · 2 generations on · 105 of its ownK110308 Prosthetic SystemOsstem Implant Co., Ltd. · 2011
Showing 5 of 183 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 183 · See all- K073247US/SS/GS SystemOsstem Implant Co., Ltd. · 2008 · cites it directly141descendants
- K081575HU/HS/HG Prosthetic SystemOsstem Implant Co., Ltd. · 2008 · cites it directly129descendants
- K081786Ziocera & Convertible SystemOsstem Implant Co., Ltd. · 2008 · 2 generations on123descendants
- K100245HS/HG Prosthetic SystemOsstem Implant Co., Ltd. · 2010 · 2 generations on111descendants
- K110308Prosthetic SystemOsstem Implant Co., Ltd. · 2011 · 2 generations on105descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −4 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −3 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −2 | K011879 | 3A Dental Implant System | Osseco Biosource, Ltd. | 2002 | — |
| −1 | K051576 | Avana Dental Implant System | Osstem Co., Ltd. | 2005 | — |
| 0 (this device) | K062030 | US System | Osstem Implant Co., Ltd. | 2006 | — |
| +1 | K073247 | US/SS/GS System | Osstem Implant Co., Ltd. | 2008 | — |
| +1 | K081575 | HU/HS/HG Prosthetic System | Osstem Implant Co., Ltd. | 2008 | — |
| +2 | K081786 | Ziocera & Convertible System | Osstem Implant Co., Ltd. | 2008 | — |
| +2 | K100245 | HS/HG Prosthetic System | Osstem Implant Co., Ltd. | 2010 | — |
| +2 | K110308 | Prosthetic System | Osstem Implant Co., Ltd. | 2011 | — |
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 |
|---|---|---|
| 2008 | 7 | 0 |
| 2009 | 5 | 0 |
| 2010 | 5 | 0 |
| 2011 | 3 | 0 |
| 2012 | 6 | 0 |
| 2013 | 8 | 0 |
| 2014 | 6 | 0 |
| 2015 | 3 | 0 |
| 2016 | 9 | 0 |
| 2017 | 10 | 0 |
| 2018 | 11 | 0 |
| 2019 | 4 | 0 |
| 2020 | 21 | 0 |
| 2021 | 13 | 0 |
| 2022 | 12 | 0 |
| 2023 | 26 | 0 |
| 2024 | 18 | 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? (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 |
|---|---|---|---|
| * | K051576 | Avana Dental Implant SystemSummary page 1…R 872.3640 Class II DZE, NIHA 3. Predicate Device: AVANA Dental Implant System, Osstem Co., Ltd, K051576 4. Description: The US system is a dental implant system made of titanium metal intended to be surgically placed in t… | 2005 |
What descends from it? (183)
See all 18310 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073247 | US/SS/GS System | 2008 | 141 |
| K081575 | HU/HS/HG Prosthetic System | 2008 | 129 |
| K073465 | US/GS Ultra Wide System | 2008 | 90 |
| K080387 | HU II / HS II Fixture System | 2008 | 77 |
| K160670 | ET US SS Prosthetic system | 2017 | 32 |
| K182091 | Osstem Abutment System | 2019 | 30 |
| K171179 | BR Type Implant System | 2018 | 1 |
| K140051 | KJ External Implant System | 2014 | 0 |
| K090377 | Sinus Quick EB System | 2009 | 0 |
| K081579 | Inventus Implant System | 2008 | 0 |
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 16 years and passes through 6 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 15 ancestors has a recall of any class.
- Of its descendants, K073247 (Osstem Implant Co., Ltd., 2008) has gone furthest, with 141 descendants of its own.
- 3 other devices also cite its predicate K051576.
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?
US System and SSII mini are intended 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. US System is for two stage surgical procedures. It is not for one stage or immediate load. SSII mini is for one and two stage surgical procedures. It is not for immediate load.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062030 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062030: US System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062030
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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