510(k) · Cleared
Cleared3I Dental Implant Accessories
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 19, 2002 as substantially equivalent to K935544 (Implant Innovations International, Inc., 1995) and 7 other predicates after an 83-day review. Its family tree reaches back 2 generations to 1989. 463 later devices descend from it.
- Decided
- Sep 19, 2002
- Review
- 83 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 2 generations to K891615 (1989). 11 ancestors in all. 463 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK891615 Surgical DrillsImplant Innovations International, Inc. · 1989
- 1 generation backK962014 3I Single Use, Disposable Drills,Taps,Burs, Etc.Implant Innovations, Inc. · 1996
- This deviceK022113 3I Dental Implant AccessoriesImplant Innovations, Inc. · 2002
- Descendant · cites it directly · 319 of its ownK030614 3I Dental ImplantsImplant Innovations, Inc. · 2003
- Descendant · 2 generations on · 318 of its ownK041402 Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004
- Descendant · 3 generations on · 317 of its ownK051189 Prevail Dental ImplantsImplant Innovations, Inc. · 2005
- Descendant · 2 generations on · 312 of its ownK051461 3I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005
- Descendant · cites it directly · 218 of its ownK040807 Mis Dental Implant SystemMis - Implant Technologies, Ltd. · 2004
Showing 5 of 463 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 463 · See all- K0306143I Dental ImplantsImplant Innovations, Inc. · 2003 · cites it directly319descendants
- K041402Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004 · 2 generations on318descendants
- K051189Prevail Dental ImplantsImplant Innovations, Inc. · 2005 · 3 generations on317descendants
- K0514613I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005 · 2 generations on312descendants
- K040807Mis Dental Implant SystemMis - Implant Technologies, Ltd. · 2004 · cites it directly218descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K891615 | Surgical Drills | Implant Innovations International, Inc. | 1989 | — |
| −1 | K962014 | 3I Single Use, Disposable Drills,Taps,Burs, Etc. | Implant Innovations, Inc. | 1996 | — |
| 0 (this device) | K022113 | 3I Dental Implant Accessories | Implant Innovations, Inc. | 2002 | — |
| +1 | K030614 | 3I Dental Implants | Implant Innovations, Inc. | 2003 | — |
| +2 | K041402 | Modification to Osseotite NT Certain Implants | Implant Innovations, Inc. | 2004 | — |
| +3 | K051189 | Prevail Dental Implants | Implant Innovations, Inc. | 2005 | — |
| +2 | K051461 | 3I Osseotite Dental Implants | Implant Innovations, Inc. | 2005 | — |
| +1 | K040807 | Mis Dental Implant System | Mis - Implant Technologies, Ltd. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 10 | 0 |
| 2008 | 11 | 0 |
| 2009 | 6 | 0 |
| 2010 | 2 | 0 |
| 2011 | 8 | 0 |
| 2012 | 13 | 0 |
| 2013 | 18 | 0 |
| 2014 | 17 | 0 |
| 2015 | 21 | 0 |
| 2016 | 23 | 0 |
| 2017 | 23 | 0 |
| 2018 | 24 | 0 |
| 2019 | 24 | 0 |
| 2020 | 30 | 0 |
| 2021 | 32 | 0 |
| 2022 | 38 | 0 |
| 2023 | 39 | 0 |
| 2024 | 46 | 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? (8)
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 |
|---|---|---|---|
| * | K935544 | 3I Standard Threaded/Self-Tapping Threaded Implants ModificationSummary page 1…leared for marketing via the following premarket notifications: K935544 - 3i Implants K952811 - 3i OralMaxillofacial… | 1995 |
| * | K952811 | 3I Oral/Maxillofacial Bone Fixation System: Stainless Steel Bone-Mesh/Plate & ScrewsSummary page 1…ollowing premarket notifications: K935544 - 3i Implants K952811 - 3i OralMaxillofacial Bone Fixation System… | 1995 |
| * | K962014 | 3I Single Use, Disposable Drills,Taps,Burs, Etc.Summary page 1…K952811 - 3i OralMaxillofacial Bone Fixation System K962014 - 3i Single Use, Disposable Drills, Taps, Burs… | 1996 |
| * | K962465 | TIL313 Abutment and Retaining Screw SystemsSummary page 1…K962014 - 3i Single Use, Disposable Drills, Taps, Burs K962465 - TIL3 13 Abutment and Retaining Screw System… | 1996 |
| * | K965077 | Single Toot Abutment System (Sta or ST Abutment ) for Single Ooth Cement Retained…Summary page 1…K962465 - TIL3 13 Abutment and Retaining Screw System K965077 - Single Tooth Abutment System… | 1997 |
| * | K992334 | Endosseous Implants and Abutments- Tin CoatingSummary page 1…K965077 - Single Tooth Abutment System K992334 - Endosseous Implants and Abutments… | 1999 |
| * | K012911 | 3I Locater Abutment System | 2001 |
| * | K013570 | Osseotite Dental Implants | 2001 |
What descends from it? (463)
See all 4636 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?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 7.5 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K030614 (Implant Innovations, Inc., 2003) has gone furthest, with 319 descendants of its own.
- 12 other devices also cite its predicate K935544.
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?
3i Dental Accessories are indicated for use in surgical and restorative applications when placing dental implants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022113 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022113: 3I Dental Implant Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022113
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