510(k) · Cleared
ClearedSteri-Oss 3.25 MM Replace Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Steri-Oss, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Nov 26, 1997 as substantially equivalent to K964220 (Steri-Oss, Inc., 1997) and 1 other predicate after a 78-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Nov 26, 1997
- Review
- 78 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K911592 (1993). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK911592 Steri-Oss Titanium Plama Spray Cylindrical ImplantSteri-Oss, Inc. · 1993
- This deviceK973402 Steri-Oss 3.25 MM Replace Dental Implant SystemSteri-Oss, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K911592 | Steri-Oss Titanium Plama Spray Cylindrical Implant | Steri-Oss, Inc. | 1993 | — |
| 0 (this device) | K973402 | Steri-Oss 3.25 MM Replace Dental Implant System | Steri-Oss, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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? (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 |
|---|---|---|---|
| * | K964220 | Replace Titanium Implant SystemSummary page 1…ce Dental Implant System Endosseous dental implant Substantial equivalence is claimed to Steri-Oss’ Replace Implants, Healing Screws, Healing Abutments, and Abutments (K964220) and to Steri-Oss’ (3.25 mm diameter) Titanium Plasma Sprayed Cylindrical Implant (K911592). Steri-Oss Inc. - September 1997 Pa… | 1997 |
| * | K911592 | Steri-Oss Titanium Plama Spray Cylindrical ImplantSummary page 1…Steri-Oss’ Replace Implants, Healing Screws, Healing Abutments, and Abutments (K964220) and to Steri-Oss’ (3.25 mm diameter) Titanium Plasma Sprayed Cylindrical Implant (K911592). Steri-Oss Inc. - September 1997 Page 1 of 3 q W - .- -3 Y Original 510(k) Steri-Oss 3.25 mm Replace Dental I… | 1993 |
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?
- 1 of the 2 ancestors has a recall of any class.
- 3 other devices also cite its predicate K964220.
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?
The intended use for this device is to serve as support for prosthetic devices to restore patient chewing function.
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/K973402 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973402: Steri-Oss 3.25 MM Replace 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/K973402
Report an extraction error
Are you the manufacturer?
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