510(k) · Cleared
Recalled · 2003Replace Titanium 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 Mar 5, 1997 after a 134-day review. The FDA summary names its predicate without a number. 24 later devices descend from it. It has been recalled once.
- Decided
- Mar 5, 1997
- Review
- 134 days
- Class
- Class II
- Product code
- DZE
- Recalls
- 1
- Predicates
- 0
24 later devices descend from it, 4 citing it directly.
- This deviceK964220 Replace Titanium Implant SystemSteri-Oss, Inc. · 1997
- Descendant · cites it directly · 17 of its ownK070905 Endosseous Dental Implant SystemSouthern Implants, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 13 of its ownK163634 External Hex ImplantsSouthern Implants (Pty), Ltd. · 2017 · Recalled
- Descendant · 2 generations on · 7 of its ownK163060 Deep Conical (DC) Implants and AccessoriesSouthern Implants (Pty), Ltd. · 2017
- Descendant · 3 generations on · 3 of its ownK193084 TIB Abutment SystemSouthern Implants (Pty), Ltd. · 2020
- Descendant · cites it directly · 3 of its ownK034014 Spi Contact Dental ImplantThommen Medical AG · 2004
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K070905Endosseous Dental Implant SystemSouthern Implants, Inc. · 2007 · cites it directly17descendants
- K163634External Hex ImplantsSouthern Implants (Pty), Ltd. · 2017 · 2 generations on13descendants
- K163060Deep Conical (DC) Implants and AccessoriesSouthern Implants (Pty), Ltd. · 2017 · 2 generations on7descendants
- K193084TIB Abutment SystemSouthern Implants (Pty), Ltd. · 2020 · 3 generations on3descendants
- K034014Spi Contact Dental ImplantThommen Medical AG · 2004 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964220 | Replace Titanium Implant System | Steri-Oss, Inc. | 1997 | — |
| +1 | K070905 | Endosseous Dental Implant System | Southern Implants, Inc. | 2007 | 1 |
| +2 | K163634 | External Hex Implants | Southern Implants (Pty), Ltd. | 2017 | 1 |
| +2 | K163060 | Deep Conical (DC) Implants and Accessories | Southern Implants (Pty), Ltd. | 2017 | — |
| +3 | K193084 | TIB Abutment System | Southern Implants (Pty), Ltd. | 2020 | — |
| +1 | K034014 | Spi Contact Dental Implant | Thommen Medical AG | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2026 | 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? (4)
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 |
|---|---|---|---|
| * | — | Steri-Oss Titanium Implants Named without a submission number | |
| * | — | Steri-Oss Healing Screws Named without a submission number | |
| * | — | Steri-Oss Healing Abutments Named without a submission number | |
| * | — | Steri-Oss Abutments Named without a submission number |
What descends from it? (24)
See all 244 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 27, 2003 | Not classified | Z-0575-03 | Other | Misprinted radiographic template plates. Misprinted labeling. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K070905 (Southern Implants, Inc., 2007) has gone furthest, with 17 descendants of its own.
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 implant is indicated for use in restoring masticatory function in the edentulous and/or partially edentulous patient.
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/K964220 · printed Nov 5, 2026
Cite this page
510(k) Report. “K964220: Replace Titanium 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/K964220
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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