510(k) · Cleared
ClearedOsseofuse Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dynamic Innovations, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Jul 14, 2011 as substantially equivalent to K032774 (Lifecore Biomedical, Inc., 2003) and 2 other predicates after a 135-day review. Its family tree reaches back 7 generations to 1990. 4 later devices descend from it.
- Decided
- Jul 14, 2011
- Review
- 135 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K894595 (1990). 30 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 6 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 5 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 4 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 3 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 2 generations backK050705 Tiunite ImplantsNobel Biocare AB · 2005 · Recalled
- 1 generation backK061410 Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System…Zimmer Dental, Inc. · 2006 · Recalled
- This deviceK110577 Osseofuse Dental Implant SystemDynamic Innovations, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK133050 One Plus Implant SystemOsseofuse, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK151970 KJ Mini Implant SystemKj Meditech Co., Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK131748 Osseofuse Dental Implant SystemOsseofuse, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK130221 Hero II Dental Implant System, UI Dental Implant SystemMedimecca Co., Ltd. · 2013
Most influential descendants
Showing 4 of 4 · See all- K133050One Plus Implant SystemOsseofuse, Inc. · 2014 · cites it directly1descendant
- K151970KJ Mini Implant SystemKj Meditech Co., Ltd. · 2016 · 2 generations on0descendants
- K131748Osseofuse Dental Implant SystemOsseofuse, Inc. · 2013 · cites it directly0descendants
- K130221Hero II Dental Implant System, UI Dental Implant SystemMedimecca Co., Ltd. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −6 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −5 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −4 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −3 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −2 | K050705 | Tiunite Implants | Nobel Biocare AB | 2005 | 1 |
| −1 | K061410 | Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System, TSV;Advent… | Zimmer Dental, Inc. | 2006 | 1 |
| 0 (this device) | K110577 | Osseofuse Dental Implant System | Dynamic Innovations, Inc. | 2011 | — |
| +1 | K133050 | One Plus Implant System | Osseofuse, Inc. | 2014 | — |
| +2 | K151970 | KJ Mini Implant System | Kj Meditech Co., Ltd. | 2016 | — |
| +1 | K131748 | Osseofuse Dental Implant System | Osseofuse, Inc. | 2013 | — |
| +1 | K130221 | Hero II Dental Implant System, UI Dental Implant System | Medimecca Co., Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 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? (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 |
|---|---|---|---|
| * | K032774 | Renova Internal Hex Implant SystemSummary page 2…Devices: The subject device is substantially equivalent to the following predicate devices: * RENOVA T M Internal Hex Implant System (Lifecore Biomedical, Inc.; K032774) *BioHorizons Internal Implant System (Abutments) (BioHorizons Implant System, Inc.; K07 1638) *Zimmer Dental Implant… | 2003 |
| * | K071638 | Biohorizons Tapered Internal Implant SystemSummary page 2…* RENOVA T M Internal Hex Implant System (Lifecore Biomedical, Inc.; K032774) *BioHorizons Internal Implant System (Abutments) (BioHorizons Implant System, Inc.; K07 1638) *Zimmer Dental Implant System (Abutments) (Zimmer Dental, Inc. ;K0614 10) Comparison to Predicate Devices: I) RENO… | 2007 |
| * | K061410 | Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System, TSV;Advent Implant…Summary page 2…*BioHorizons Internal Implant System (Abutments) (BioHorizons Implant System, Inc.; K07 1638) *Zimmer Dental Implant System (Abutments) (Zimmer Dental, Inc. ;K0614 10) Comparison to Predicate Devices: I) RENOVA TMInternal Hex Implant System The OsseoFuse Dental Implant system has a… | 2006 |
What descends from it? (4)
3 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 21 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 8 of the 30 ancestors have a recall of any class.
- Of its descendants, K133050 (Osseofuse, Inc., 2014) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K032774.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 OsseoFuse 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 dedicated for one and two stage surgical procedures and not dedicated for immediate loading.
This system is intended for delayed loading.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110577 · printed Nov 3, 2026
Cite this page
510(k) Report. “K110577: Osseofuse 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/K110577
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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