510(k) · Cleared
ClearedModification to Osseotite NT Certain Implants
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 Jun 16, 2004 as substantially equivalent to K031475 (Implant Innovations, Inc., 2003) and 2 other predicates after a 21-day review. Its family tree reaches back 5 generations to 1993. 318 later devices descend from it.
- Decided
- Jun 16, 2004
- Review
- 21 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K925765 (1993). 57 ancestors in all, the oldest K781060 (1978). 318 later devices descend from it, 5 citing it directly.
- Root · 5 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 4 generations backK994376 Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating…Friadent GmbH · 2000
- 3 generations backK014235 Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 2002
- 2 generations backK022009 3I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc. · 2002
- 1 generation backK031475 Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2003
- This deviceK041402 Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004
- Descendant · cites it directly · 317 of its ownK051189 Prevail Dental ImplantsImplant Innovations, Inc. · 2005
- Descendant · cites it directly · 312 of its ownK051461 3I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005
- Descendant · 2 generations on · 211 of its ownK063286 Osseotite; Osseotite NT; XP; TG OsseotiteImplant Innovations, Inc. · 2007 · Recalled
- Descendant · cites it directly · 209 of its ownK063341 3I Osseotite Certain Dental ImplantsImplant Innovations, Inc. · 2007 · Recalled
- Descendant · 3 generations on · 196 of its ownK120414 Osseospeed PlusAstra Tech AB · 2012
Showing 5 of 318 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 318 · See all- K051189Prevail Dental ImplantsImplant Innovations, Inc. · 2005 · cites it directly317descendants
- K0514613I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005 · cites it directly312descendants
- K063286Osseotite; Osseotite NT; XP; TG OsseotiteImplant Innovations, Inc. · 2007 · 2 generations on211descendants
- K0633413I Osseotite Certain Dental ImplantsImplant Innovations, Inc. · 2007 · cites it directly209descendants
- K120414Osseospeed PlusAstra Tech AB · 2012 · 3 generations on196descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K925765 | Branemark System Standard 3.75MM Fixture | Nobelpharma USA, Inc. | 1993 | — |
| −4 | K994376 | Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2… | Friadent GmbH | 2000 | — |
| −3 | K014235 | Osseotite NT Dental Implants & Accessories | Implant Innovations, Inc. | 2002 | — |
| −2 | K022009 | 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants | Implant Innovations, Inc. | 2002 | — |
| −1 | K031475 | Osseotite NT Certain Implants | Implant Innovations, Inc. | 2003 | — |
| 0 (this device) | K041402 | Modification to Osseotite NT Certain Implants | Implant Innovations, Inc. | 2004 | — |
| +1 | K051189 | Prevail Dental Implants | Implant Innovations, Inc. | 2005 | — |
| +1 | K051461 | 3I Osseotite Dental Implants | Implant Innovations, Inc. | 2005 | — |
| +2 | K063286 | Osseotite; Osseotite NT; XP; TG Osseotite | Implant Innovations, Inc. | 2007 | 5 |
| +1 | K063341 | 3I Osseotite Certain Dental Implants | Implant Innovations, Inc. | 2007 | 10 |
| +3 | K120414 | Osseospeed Plus | Astra Tech AB | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 5 | 0 |
| 1990 | 5 | 0 |
| 1992 | 2 | 0 |
| 1994 | 6 | 0 |
| 1995 | 4 | 0 |
| 1996 | 5 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2007 | 6 | 0 |
| 2008 | 6 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 6 | 0 |
| 2012 | 4 | 0 |
| 2013 | 8 | 0 |
| 2014 | 11 | 0 |
| 2015 | 12 | 0 |
| 2016 | 14 | 0 |
| 2017 | 14 | 0 |
| 2018 | 13 | 0 |
| 2019 | 18 | 0 |
| 2020 | 19 | 0 |
| 2021 | 19 | 0 |
| 2022 | 31 | 0 |
| 2023 | 32 | 0 |
| 2024 | 40 | 0 |
| 2025 | 38 | 0 |
| 2026 | 22 | 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? (3)
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 |
|---|---|---|---|
| * | K031475 | Osseotite NT Certain ImplantsSummary page 1…sification Dental Devices Panel 21 CFR § 872.3640 Predicate OSSEOTITE NT Certain Implants Devices K031475 OSSEOTITE NT Dental Implants K014235 3i Implants… | 2003 |
| * | K014235 | Osseotite NT Dental Implants & AccessoriesSummary page 1…redicate OSSEOTITE NT Certain Implants Devices K031475 OSSEOTITE NT Dental Implants K014235 3i Implants K030614 Performance Performance standards have not… | 2002 |
| * | K030614 | 3I Dental ImplantsSummary page 1…K031475 OSSEOTITE NT Dental Implants K014235 3i Implants K030614 Performance Performance standards have not been established by the FDA under Section 514… | 2003 |
What descends from it? (318)
See all 3185 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 11 years and passes through 3 companies; a new generation was cleared every 11 months on median.
- 8 of the 57 ancestors have a recall of any class.
- Of its descendants, K051189 (Implant Innovations, Inc., 2005) has gone furthest, with 317 descendants of its own.
- 6 other devices also cite its predicate K031475.
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?
Intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment to restore a patient's chewing function.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041402 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041402: Modification to Osseotite NT Certain Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041402
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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