510(k) · Cleared
ClearedOsseolink Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Global Implant Solutions, LLC · DZE Implant, Endosseous, Root-Form
Cleared on Oct 6, 2009 as substantially equivalent to K013227 (Sulzer Dental, Inc., 2001) and 1 other predicate after a 105-day review. Its family tree reaches back 6 generations to 1990.
- Decided
- Oct 6, 2009
- Review
- 105 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K894595 (1990). 22 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 5 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 4 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 3 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 2 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 1 generation backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- This deviceK091878 Osseolink Dental Implant SystemGlobal Implant Solutions, LLC · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −5 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −4 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −3 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −2 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −1 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| 0 (this device) | K091878 | Osseolink Dental Implant System | Global Implant Solutions, LLC | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 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 |
|---|---|---|---|
| * | K013227 | Screw Vent Implant; Tapered Screw Vent Implant | 2001 |
| * | K050258 | Groovy ImplantsSummary page 3…he two-stage protocol is followed. Predicate Device(s) 1. Sulzer Dental, Inc. - Screw Vent & Tapered Screw Vent - (KO1 3227) 2. Nobel Biocare, LLC - Groovy Implants - (K050258) Safety and Effectiveness By definition, a device is substantially equivalent to a predicate device when the device has the sam… | 2005 |
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 19 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 5 of the 22 ancestors have a recall of any class.
- 14 other devices also cite its predicate K013227.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
OsseoLink dental implants are 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. The OsseoLink Dental System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate…
Read the full statement (161 words)
OsseoLink dental implants are 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. The OsseoLink Dental System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. The placement of individual 0 3.5 mm diameter implants in the molar region in not recommended.
OsseoLink prosthetic abutments are intended for use with OsseoLink dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. OsseoLink cover screws are used when submerged healing is desired in two stage implant surgery procedures. OsseoLink healing abutments are used at the time of implant placement when non-submerged (i.e., single-stage) surgical placement is indicated or following the uncovering of an implant when the two-stage protocol is followed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091878 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091878: Osseolink 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/K091878
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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