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 May 8, 2025 as substantially equivalent to K182293 (Synoross Dba Osseone, 2019) and 2 other predicates after a 587-day review. Its family tree reaches back 11 generations to 1990.
- Decided
- May 8, 2025
- Review
- 587 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K894595 (1990). 27 ancestors in all. No later device cites it as a predicate yet.
- Root · 11 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 7 generations between
- 3 generations backK170372 SpiralTech Dental Implant SystemSpiraltech Superior Dental Implants, Inc. · 2017
- 2 generations backK182293 OsseOne Dental Implant SystemSynoross Dba Osseone · 2019
- 1 generation backK240837 TOV Dental Implant SystemRdj Tov Implant, Ltd. · 2024
- This deviceK233271 OsseOne Dental Implant SystemSynoross Dba Osseone · 2025
Show all 11 generations
- Root · 11 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 10 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 9 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 8 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 7 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 6 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 5 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 4 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- 3 generations backK170372 SpiralTech Dental Implant SystemSpiraltech Superior Dental Implants, Inc. · 2017
- 2 generations backK182293 OsseOne Dental Implant SystemSynoross Dba Osseone · 2019
- 1 generation backK240837 TOV Dental Implant SystemRdj Tov Implant, Ltd. · 2024
- This deviceK233271 OsseOne Dental Implant SystemSynoross Dba Osseone · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −10 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −9 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −8 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −7 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −6 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −5 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −4 | K071370 | Nobelactive Internal Connection Implant | Nobel Biocare AB | 2007 | 4 |
| −3 | K170372 | SpiralTech Dental Implant System | Spiraltech Superior Dental Implants, Inc. | 2017 | — |
| −2 | K182293 | OsseOne Dental Implant System | Synoross Dba Osseone | 2019 | — |
| −1 | K240837 | TOV Dental Implant System | Rdj Tov Implant, Ltd. | 2024 | — |
| 0 (this device) | K233271 | OsseOne Dental Implant System | Synoross Dba Osseone | 2025 | — |
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 |
| 2017 | 1 | 0 |
| 2019 | 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 |
|---|---|---|---|
| * | K182293 | OsseOne Dental Implant SystemSummary page 5…implant. OsseoMax Hex comes in 4.6, and 5.4 mm diameter with lengths of 8, 10mm. OsseoMax Hex are only restored using hex ball attachments or Denture Lock hex cleared in K182293. Tapered Multipurpose Indexed Hex Abutments have a 3.75mm platform diameter with a total height of 10.98mm. Heigh… | 2019 |
| * | K240837 | TOV Dental Implant System Cleared while this submission was under review Summary page 8…acement force and torque. Primary Predicate Device: OsseoPlus and OsseoLock from OsseOne Dental Implant Systems K182293 Reference Predicates: TOV Dental Implant System K240837 Surgikor Dental Implant System K182615 Substantial Equivalence: The OsseOne Dental Implant System is substantially equivalent to… | 2024 |
| * | K182615 | Surgikor Dental Implant SystemSummary page 8…dicate Device: OsseoPlus and OsseoLock from OsseOne Dental Implant Systems K182293 Reference Predicates: TOV Dental Implant System K240837 Surgikor Dental Implant System K182615 Substantial Equivalence: The OsseOne Dental Implant System is substantially equivalent to the previous version of the OsseOne De… | 2019 |
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 35 years and passes through 7 companies; a new generation was cleared every 1.6 years on median.
- 5 of the 27 ancestors have a recall of any class.
- 1 other device also cites its predicate K182293.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 OsseOne Dental Implant System 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 patient’s esthetics and chewing function. OsseOne Dental implants are intended for single or multiple unit restorations on splinted or non-splinted applications. OsseOne Dental implants 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233271 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233271: OsseOne 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/K233271
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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