510(k) · Cleared
ClearedCertain Prevail Dental Implant
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 Feb 23, 2007 as substantially equivalent to K031632 (Implant Innovations, Inc., 2003) and 1 other predicate after a 256-day review. Its family tree reaches back 7 generations to 1993. 4 later devices descend from it.
- Decided
- Feb 23, 2007
- Review
- 256 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K925765 (1993). 60 ancestors in all, the oldest K781060 (1978). 4 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 6 generations backK994376 Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating…Friadent GmbH · 2000
- 5 generations backK014235 Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 2002
- 4 generations backK022009 3I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc. · 2002
- 3 generations backK031475 Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2003
- 2 generations backK041402 Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004
- 1 generation backK051189 Prevail Dental ImplantsImplant Innovations, Inc. · 2005
- This deviceK061629 Certain Prevail Dental ImplantImplant Innovations, Inc. · 2007
- Descendant · cites it directly · 2 of its ownK063106 Revois Implant SystemCurasan AG · 2007
- Descendant · 2 generations on · 0 of its ownK113539 Revois Pro Implant StsyemRiemser Arzneimittel AG · 2013
- Descendant · 2 generations on · 0 of its ownK113042 Revois Implant SystemRiemser Arzneimittel AG · 2013
- Descendant · cites it directly · 0 of its ownK082749 Omni-TightBasic Dental Implant Systems, Inc. · 2008
Most influential descendants
Showing 4 of 4 · See all- K063106Revois Implant SystemCurasan AG · 2007 · cites it directly2descendants
- K113539Revois Pro Implant StsyemRiemser Arzneimittel AG · 2013 · 2 generations on0descendants
- K113042Revois Implant SystemRiemser Arzneimittel AG · 2013 · 2 generations on0descendants
- K082749Omni-TightBasic Dental Implant Systems, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K925765 | Branemark System Standard 3.75MM Fixture | Nobelpharma USA, Inc. | 1993 | — |
| −6 | K994376 | Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2… | Friadent GmbH | 2000 | — |
| −5 | K014235 | Osseotite NT Dental Implants & Accessories | Implant Innovations, Inc. | 2002 | — |
| −4 | K022009 | 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants | Implant Innovations, Inc. | 2002 | — |
| −3 | K031475 | Osseotite NT Certain Implants | Implant Innovations, Inc. | 2003 | — |
| −2 | K041402 | Modification to Osseotite NT Certain Implants | Implant Innovations, Inc. | 2004 | — |
| −1 | K051189 | Prevail Dental Implants | Implant Innovations, Inc. | 2005 | — |
| 0 (this device) | K061629 | Certain Prevail Dental Implant | Implant Innovations, Inc. | 2007 | — |
| +1 | K063106 | Revois Implant System | Curasan AG | 2007 | — |
| +2 | K113539 | Revois Pro Implant Stsyem | Riemser Arzneimittel AG | 2013 | — |
| +2 | K113042 | Revois Implant System | Riemser Arzneimittel AG | 2013 | — |
| +1 | K082749 | Omni-Tight | Basic Dental Implant Systems, Inc. | 2008 | — |
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 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 2 | 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 |
|---|---|---|---|
| * | K031632 | Osseotite Iol Implants and Osseotite Certain Iol ImplantsSummary page 1…Dental Devices Panel 21 CFR § 872.3640 Predicate OSSEOTITE IOL Dental Implants Devices K031632, K051189 Performance Performance standards have not been established by the… | 2003 |
| * | K051189 | Prevail Dental ImplantsSummary page 1…l Devices Panel 21 CFR § 872.3640 Predicate OSSEOTITE IOL Dental Implants Devices K031632, K051189 Performance Performance standards have not been established by the FDA under… | 2005 |
What descends from it? (4)
2 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 14 years and passes through 3 companies; a new generation was cleared every 12 months on median.
- 8 of the 60 ancestors have a recall of any class.
- Of its descendants, K063106 (Curasan AG, 2007) has gone furthest, with 2 descendants of its own.
- 6 other devices also cite its predicate K031632.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restoration and in partially or fully edentulous spans with multiple single teeth, freestanding bridges and to retain overdentures.
In addition, when a minimum of 4 implants, > 10 mm in length, are placed in the mandible and splinted in the anterior region, immediate loading is indicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061629 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061629: Certain Prevail Dental Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061629
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