510(k) · Cleared
ClearedOsseOne Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synoross Dba Osseone · DZE Implant, Endosseous, Root-Form
Cleared on Feb 15, 2019 as substantially equivalent to K170372 (Spiraltech Superior Dental Implants, Inc., 2017) after a 175-day review. Its family tree reaches back 9 generations to 1990. 5 later devices descend from it.
- Decided
- Feb 15, 2019
- Review
- 175 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K894595 (1990). 23 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 5 generations between
- 3 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 2 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- 1 generation backK170372 SpiralTech Dental Implant SystemSpiraltech Superior Dental Implants, Inc. · 2017
- This deviceK182293 OsseOne Dental Implant SystemSynoross Dba Osseone · 2019
- Descendant · cites it directly · 4 of its ownK240837 TOV Dental Implant SystemRdj Tov Implant, Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK250872 Bioline Dental Implant SystemBioline Dental Implant Systems, Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK233271 OsseOne Dental Implant SystemSynoross Dba Osseone · 2025
- Descendant · 2 generations on · 0 of its ownK250176 DAND Dental Implant SystemD.A.N.D. Metal Industries North, Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK243094 Quickdent Dental Implant SystemQuickdent Devices Private, Ltd. · 2024
Show all 9 generations
- Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 8 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 7 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 6 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 5 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 4 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 3 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 2 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- 1 generation backK170372 SpiralTech Dental Implant SystemSpiraltech Superior Dental Implants, Inc. · 2017
- This deviceK182293 OsseOne Dental Implant SystemSynoross Dba Osseone · 2019
Most influential descendants
Showing 5 of 5 · See all- K240837TOV Dental Implant SystemRdj Tov Implant, Ltd. · 2024 · cites it directly4descendants
- K250872Bioline Dental Implant SystemBioline Dental Implant Systems, Ltd. · 2025 · 2 generations on0descendants
- K233271OsseOne Dental Implant SystemSynoross Dba Osseone · 2025 · cites it directly0descendants
- K250176DAND Dental Implant SystemD.A.N.D. Metal Industries North, Ltd. · 2025 · 2 generations on0descendants
- K243094Quickdent Dental Implant SystemQuickdent Devices Private, Ltd. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −8 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −7 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −6 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −5 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −4 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −3 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −2 | K071370 | Nobelactive Internal Connection Implant | Nobel Biocare AB | 2007 | 4 |
| −1 | K170372 | SpiralTech Dental Implant System | Spiraltech Superior Dental Implants, Inc. | 2017 | — |
| 0 (this device) | K182293 | OsseOne Dental Implant System | Synoross Dba Osseone | 2019 | — |
| +1 | K240837 | TOV Dental Implant System | Rdj Tov Implant, Ltd. | 2024 | — |
| +2 | K250872 | Bioline Dental Implant System | Bioline Dental Implant Systems, Ltd. | 2025 | — |
| +1 | K233271 | OsseOne Dental Implant System | Synoross Dba Osseone | 2025 | — |
| +2 | K250176 | DAND Dental Implant System | D.A.N.D. Metal Industries North, Ltd. | 2025 | — |
| +2 | K243094 | Quickdent Dental Implant System | Quickdent Devices Private, Ltd. | 2024 | — |
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 |
| 2002 | 3 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K170372 | SpiralTech Dental Implant SystemSummary page 5…ng to ISO 10993-5 was conducted on implants and abutments ready for final packaging. Primary Predicate Device: SpiralTech Dental Implant System Ultimate Hex and Esi Hex K170372 Reference Devices: Zest Dental Solutions K083324 Locator Abutments and Cortex K090709 Substantial Equivalence: OsseOne Dental Im… | 2017 |
| † | K083324 | Locator Implant Anchor Attachment System | 2009 |
| † | K090709 | Cortex Dental Implant System | 2009 |
What descends from it? (5)
2 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 29 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- 5 of the 23 ancestors have a recall of any class.
- Of its descendants, K240837 (Rdj Tov Implant, Ltd., 2024) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K170372.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
OsseOne Dental Implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patients esthetics and chewing function. OsseOne implants are intended for single or multiple unit restorations on splinted or non-splinted applications. OsseoPlus and OsseoLock are intended for immediate loading when good primary stability is…
Read the full statement (126 words)
OsseOne Dental Implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patients esthetics and chewing function. OsseOne implants are intended for single or multiple unit restorations on splinted or non-splinted applications. OsseoPlus and OsseoLock are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants can also be used for loading after a conventional healing period. OsseoLock 3.3 implants are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible. Mandibular central and lateral incisors must be splinted if using two or more 3.3 implants adjacent to one another.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K182293 · printed Nov 5, 2026
Cite this page
510(k) Report. “K182293: OsseOne Dental Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182293
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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