510(k) · Cleared
ClearedEndosseous Implants and Abutments- Tin Coating
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Implant Innovations, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Oct 8, 1999 after an 87-day review. The FDA summary names its predicate without a number. 542 later devices descend from it.
- Decided
- Oct 8, 1999
- Review
- 87 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 0
542 later devices descend from it, 4 citing it directly.
- This deviceK992334 Endosseous Implants and Abutments- Tin CoatingImplant Innovations, Inc. · 1999
- Descendant · cites it directly · 463 of its ownK022113 3I Dental Implant AccessoriesImplant Innovations, Inc. · 2002
- Descendant · cites it directly · 332 of its ownK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- Descendant · 2 generations on · 331 of its ownK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 319 of its ownK030614 3I Dental ImplantsImplant Innovations, Inc. · 2003
- Descendant · 3 generations on · 318 of its ownK041402 Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004
Showing 5 of 542 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 542 · See all- K0221133I Dental Implant AccessoriesImplant Innovations, Inc. · 2002 · cites it directly463descendants
- K022795Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002 · cites it directly332descendants
- K030463Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · 2 generations on331descendants
- K0306143I Dental ImplantsImplant Innovations, Inc. · 2003 · 2 generations on319descendants
- K041402Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004 · 3 generations on318descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992334 | Endosseous Implants and Abutments- Tin Coating | Implant Innovations, Inc. | 1999 | — |
| +1 | K022113 | 3I Dental Implant Accessories | Implant Innovations, Inc. | 2002 | — |
| +1 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| +2 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| +2 | K030614 | 3I Dental Implants | Implant Innovations, Inc. | 2003 | — |
| +3 | K041402 | Modification to Osseotite NT Certain Implants | Implant Innovations, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 5 | 0 |
| 2005 | 9 | 0 |
| 2006 | 5 | 0 |
| 2007 | 13 | 0 |
| 2008 | 20 | 0 |
| 2009 | 9 | 0 |
| 2010 | 4 | 0 |
| 2011 | 17 | 0 |
| 2012 | 17 | 0 |
| 2013 | 23 | 0 |
| 2014 | 21 | 0 |
| 2015 | 24 | 0 |
| 2016 | 29 | 0 |
| 2017 | 26 | 0 |
| 2018 | 26 | 0 |
| 2019 | 25 | 0 |
| 2020 | 33 | 0 |
| 2021 | 32 | 0 |
| 2022 | 39 | 0 |
| 2023 | 44 | 0 |
| 2024 | 48 | 0 |
| 2025 | 42 | 0 |
| 2026 | 26 | 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 |
|---|---|---|---|
| * | — | Current 3i implant/abutments Named without a submission number | |
| * | — | Competitive systems using TiN coatings Named without a submission number |
What descends from it? (542)
See all 5424 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?
- Of its descendants, K022113 (Implant Innovations, Inc., 2002) has gone furthest, with 463 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?
Endosseous implants and abutments are indicated for surgical placement into the upper and lower jar arches-as permanent support for prosthetic appliances, to restore a patient's masticatory function. Proposed Titanium Nitride ("TiN") coating applied to implants/abutments improves the overall esthetics of the completed restoration.
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/K992334 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992334: Endosseous Implants and Abutments- Tin Coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992334
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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