510(k) · Cleared
ClearedTIL313 Abutment and Retaining Screw Systems
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 Sep 20, 1996 after an 87-day review. The FDA summary names no predicate by number. 673 later devices descend from it.
- Decided
- Sep 20, 1996
- Review
- 87 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 0
673 later devices descend from it, 2 citing it directly.
- This deviceK962465 TIL313 Abutment and Retaining Screw SystemsImplant Innovations, Inc. · 1996
- Descendant · cites it directly · 476 of its ownK032263 3I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004 · Recalled
- Descendant · cites it directly · 463 of its ownK022113 3I Dental Implant AccessoriesImplant Innovations, Inc. · 2002
- Descendant · 2 generations on · 441 of its ownK042658 Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001…Nobel Biocare Uas, Inc. · 2004
- Descendant · 2 generations on · 327 of its ownK043042 Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004
- Descendant · 2 generations on · 319 of its ownK030614 3I Dental ImplantsImplant Innovations, Inc. · 2003
Showing 5 of 673 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 673 · See all- K0322633I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004 · cites it directly476descendants
- K0221133I Dental Implant AccessoriesImplant Innovations, Inc. · 2002 · cites it directly463descendants
- K042658Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004Nobel Biocare Uas, Inc. · 2004 · 2 generations on441descendants
- K043042Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004 · 2 generations on327descendants
- K0306143I Dental ImplantsImplant Innovations, Inc. · 2003 · 2 generations on319descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K962465 | TIL313 Abutment and Retaining Screw Systems | Implant Innovations, Inc. | 1996 | — |
| +1 | K032263 | 3I Patient-Specific Dental Abutment and Overdenture Bar | Implant Innovations, Inc. | 2004 | 1 |
| +1 | K022113 | 3I Dental Implant Accessories | Implant Innovations, Inc. | 2002 | — |
| +2 | K042658 | Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004… | Nobel Biocare Uas, Inc. | 2004 | — |
| +2 | K043042 | Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052 | Nobel Biocare AB | 2004 | — |
| +2 | K030614 | 3I Dental Implants | Implant Innovations, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 6 | 0 |
| 2005 | 7 | 0 |
| 2006 | 8 | 0 |
| 2007 | 14 | 0 |
| 2008 | 13 | 0 |
| 2009 | 16 | 0 |
| 2010 | 11 | 0 |
| 2011 | 20 | 0 |
| 2012 | 21 | 0 |
| 2013 | 27 | 0 |
| 2014 | 30 | 0 |
| 2015 | 34 | 0 |
| 2016 | 38 | 0 |
| 2017 | 32 | 0 |
| 2018 | 34 | 0 |
| 2019 | 31 | 0 |
| 2020 | 48 | 0 |
| 2021 | 45 | 0 |
| 2022 | 46 | 0 |
| 2023 | 49 | 0 |
| 2024 | 62 | 0 |
| 2025 | 50 | 0 |
| 2026 | 29 | 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?
The FDA summary names no predicate by number.
What descends from it? (673)
See all 6732 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, K032263 (Implant Innovations, Inc., 2004) has gone furthest, with 476 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?
Abutments are designed for use in dental implant surgery. The 3i system includes a variety of types and sizes of specially designed bone-implantable titanium and titanium alloy implants and abutments. The implants are surgically inserted into upper and/or lower jawbones and upon healing an abutment may be placed on the implant, extending the implant's coronal aspect through the soft tissues and into the oral cavity. A prostheses is then attached to the…
Read the full statement (109 words)
Abutments are designed for use in dental implant surgery. The 3i system includes a variety of types and sizes of specially designed bone-implantable titanium and titanium alloy implants and abutments. The implants are surgically inserted into upper and/or lower jawbones and upon healing an abutment may be placed on the implant, extending the implant's coronal aspect through the soft tissues and into the oral cavity. A prostheses is then attached to the Abutment.
A successfully osseointegrated implant will achieve a firm and direct connection between the living bone and the surface of the titanium or titanium alloy implant when surgically implanted under controlled conditions, per well known clinical studies.
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/K962465 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962465: TIL313 Abutment and Retaining Screw Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962465
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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