510(k) · Cleared
Recalled · Class II · 20163I Osseotite Certain Dental 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 Apr 30, 2007 as substantially equivalent to K874590 (Implant Innovations International, Inc., 1988) and 10 other predicates after a 175-day review. Its family tree reaches back 8 generations to 1993. 209 later devices descend from it. It has been recalled 10 times.
- Decided
- Apr 30, 2007
- Review
- 175 days
- Class
- Class II
- Product code
- DZE
- Recalls
- 10
- Predicates
- 12
Its longest line of descent runs back 8 generations to K925765 (1993). 61 ancestors in all, the oldest K781060 (1978). 209 later devices descend from it, 15 citing it directly.
- Root · 8 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 7 generations backK994376 Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating…Friadent GmbH · 2000
- 6 generations backK014235 Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 2002
- 5 generations backK022009 3I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc. · 2002
- 4 generations backK031475 Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2003
- 3 generations backK041402 Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004
- 2 generations backK051189 Prevail Dental ImplantsImplant Innovations, Inc. · 2005
- 1 generation backK051461 3I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005
- This deviceK063341 3I Osseotite Certain Dental ImplantsImplant Innovations, Inc. · 2007
- Descendant · cites it directly · 86 of its ownK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- Descendant · cites it directly · 51 of its ownK173908 DESS Dental Smart SolutionsTerrats Medical SL · 2018
- Descendant · 2 generations on · 38 of its ownK191986 DESS Dental Smart SolutionsTerrats Medical SL · 2019
- Descendant · cites it directly · 27 of its ownK100724 Osseotite II Model XifossxxxBiomet 3i, Inc. · 2011 · Recalled
- Descendant · cites it directly · 27 of its ownK083480 Inclusive Zirconia Abutment BlanksInclusive Dental Solutions · 2009
Showing 5 of 209 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 209 · See all- K170588DESS Dental Smart SolutionsTerrats Medical SL · 2017 · cites it directly86descendants
- K173908DESS Dental Smart SolutionsTerrats Medical SL · 2018 · cites it directly51descendants
- K191986DESS Dental Smart SolutionsTerrats Medical SL · 2019 · 2 generations on38descendants
- K100724Osseotite II Model XifossxxxBiomet 3i, Inc. · 2011 · cites it directly27descendants
- K083480Inclusive Zirconia Abutment BlanksInclusive Dental Solutions · 2009 · cites it directly27descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K925765 | Branemark System Standard 3.75MM Fixture | Nobelpharma USA, Inc. | 1993 | — |
| −7 | K994376 | Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2… | Friadent GmbH | 2000 | — |
| −6 | K014235 | Osseotite NT Dental Implants & Accessories | Implant Innovations, Inc. | 2002 | — |
| −5 | K022009 | 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants | Implant Innovations, Inc. | 2002 | — |
| −4 | K031475 | Osseotite NT Certain Implants | Implant Innovations, Inc. | 2003 | — |
| −3 | K041402 | Modification to Osseotite NT Certain Implants | Implant Innovations, Inc. | 2004 | — |
| −2 | K051189 | Prevail Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −1 | K051461 | 3I Osseotite Dental Implants | Implant Innovations, Inc. | 2005 | — |
| 0 (this device) | K063341 | 3I Osseotite Certain Dental Implants | Implant Innovations, Inc. | 2007 | — |
| +1 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
| +1 | K173908 | DESS Dental Smart Solutions | Terrats Medical SL | 2018 | — |
| +2 | K191986 | DESS Dental Smart Solutions | Terrats Medical SL | 2019 | — |
| +1 | K100724 | Osseotite II Model Xifossxxx | Biomet 3i, Inc. | 2011 | 5 |
| +1 | K083480 | Inclusive Zirconia Abutment Blanks | Inclusive Dental Solutions | 2009 | — |
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 |
|---|---|---|
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 8 | 0 |
| 2015 | 10 | 0 |
| 2016 | 6 | 0 |
| 2017 | 6 | 0 |
| 2018 | 9 | 0 |
| 2019 | 14 | 0 |
| 2020 | 11 | 0 |
| 2021 | 14 | 0 |
| 2022 | 22 | 0 |
| 2023 | 25 | 0 |
| 2024 | 28 | 0 |
| 2025 | 28 | 0 |
| 2026 | 18 | 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? (12)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K874590 | Innovative Implants and Cover ScrewsSummary page 1…Dental Devices Panel 21 CFR § 872.3640 Predicate 31 OSSEOTITE Certain Dental Implants Devices K874590, K935544, K972444, K980549, K983347, K022009, K031475, K030164, K031362,… | 1988 |
| * | K935544 | 3I Standard Threaded/Self-Tapping Threaded Implants ModificationSummary page 1…Devices Panel 21 CFR § 872.3640 Predicate 31 OSSEOTITE Certain Dental Implants Devices K874590, K935544, K972444, K980549, K983347, K022009, K031475, K030164, K031362, K0414… | 1995 |
| * | K972444 | 3I Innovative Implants and Cover ScrewsSummary page 1…Panel 21 CFR § 872.3640 Predicate 31 OSSEOTITE Certain Dental Implants Devices K874590, K935544, K972444, K980549, K983347, K022009, K031475, K030164, K031362, K041402,… | 1997 |
| * | K980549 | Osseotite Dental Implant SystemSummary page 1…21 CFR § 872.3640 Predicate 31 OSSEOTITE Certain Dental Implants Devices K874590, K935544, K972444, K980549, K983347, K022009, K031475, K030164, K031362, K041402,… | 1998 |
| * | K983347 | Osseotite Dental ImplantsSummary page 1…21 CFR § 872.3640 Predicate 31 OSSEOTITE Certain Dental Implants Devices K874590, K935544, K972444, K980549, K983347, K022009, K031475, K030164, K031362, K041402, K051 189… | 1999 |
| * | K022009 | 3I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsSummary page 1…31 OSSEOTITE Certain Dental Implants Devices K874590, K935544, K972444, K980549, K983347, K022009, K031475, K030164, K031362, K041402, K051 189, K05 1461 Performance… | 2002 |
| * | K031475 | Osseotite NT Certain ImplantsSummary page 1…31 OSSEOTITE Certain Dental Implants Devices K874590, K935544, K972444, K980549, K983347, K022009, K031475, K030164, K031362, K041402, K051 189, K05 1461 Performance Perfor… | 2003 |
| Kept off the family tree | K030164 | FDA’s K030164 is Non-Sterile, Powder-Free, Polymer Coated, Natural and/or Violet and Black… Our reading of the summary gave K030164, FDA’s number for Non-Sterile, Powder-Free, Polymer Coated, Natural and/or… (Yty Industry (Manjung) Sdn Bhd). Its FDA name has none of the distinctive words the summary uses for the device it names, “3i OSSEOTITE Certain Dental Implants”. Kept off the family tree. Summary page 1…SEOTITE Certain Dental Implants Devices K874590, K935544, K972444, K980549, K983347, K022009, K031475, K030164, K031362, K041402, K051 189, K05 1461 Performance Performance sta… | 2003 |
| * | K031632 | Osseotite Iol Implants and Osseotite Certain Iol Implants Our reading of the summary gave K031362, FDA’s number for Lac-Mac Limited Innerbloc Various O.R. Drape Based on the… (Lac Mac, Ltd.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “3i OSSEOTITE Certain Dental Implants”. | 2003 |
| * | K041402 | Modification to Osseotite NT Certain ImplantsSummary page 1…evices K874590, K935544, K972444, K980549, K983347, K022009, K031475, K030164, K031362, K041402, K051 189, K05 1461 Performance Performance standards have not been established… | 2004 |
| * | K051189 | Prevail Dental ImplantsSummary page 1…935544, K972444, K980549, K983347, K022009, K031475, K030164, K031362, K041402, K051 189, K05 1461 Performance Performance standards have not been established by the FDA… | 2005 |
| * | K051461 | 3I Osseotite Dental ImplantsSummary page 1…72444, K980549, K983347, K022009, K031475, K030164, K031362, K041402, K051 189, K05 1461 Performance Performance standards have not been established by the FDA under Sec… | 2005 |
What descends from it? (209)
See all 20915 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170588 | DESS Dental Smart Solutions | 2017 | 86 |
| K173908 | DESS Dental Smart Solutions | 2018 | 51 |
| K100724 | Osseotite II Model Xifossxxx | 2011 | 27 |
| K083480 | Inclusive Zirconia Abutment Blanks | 2009 | 27 |
| K122300 | T3 Dental Implant | 2013 | 22 |
| K113779 | Conelog Implant System | 2012 | 14 |
| K140934 | Hiossen Implant System | 2014 | 13 |
| K141544 | Zimmer ZFX Titanium Abutment for Biomet 3I Certain Implant System | 2014 | 12 |
| K180282 | MIS Internal Hex Dental Implant System | 2018 | 11 |
| K160119 | NobelSpeedy Groovy | 2016 | 7 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 8, 2016 | Class II | Z-2845-2016 | Packaging process control | Product was incorrectly packaged. |
| Nov 25, 2015 | Class II | Z-2520-2016 | Packaging | Pouches may not have been sealed during packing. |
| Nov 25, 2015 | Class II | Z-2485-2016 | Packaging | Pouches may not have been sealed during packing. |
| Nov 25, 2015 | Class II | Z-2516-2016 | Packaging | Pouches may not have been sealed during packing. |
| Nov 25, 2015 | Class II | Z-2488-2016 | Packaging | Pouches may not have been sealed during packing. |
| Nov 25, 2015 | Class II | Z-2483-2016 | Packaging | Pouches may not have been sealed during packing. |
| Jun 10, 2013 | Class II | Z-2208-2013 | Device Design | One of the dental implants do not have the internal hex feature. One of the dental implants do not have the internal thread feature. |
| Aug 3, 2012 | Class II | Z-0119-2013 | Process control | Biomet 3i recalled their Osseotite Tapered Certain Implant, Model # INT510 due to a small percentage of the devices are missing the internal threading. |
| Mar 23, 2012 | Class II | Z-2158-2012 | Process control | Biomet 3i is recalling their product Full Osseotite Tapered Certain Implant IFNT611. The depth of the implant's internal hex is too shallow. The condition, if present, may prevent the driver; cover screw or abutment from fully engaging… |
| Nov 4, 2011 | Class II | Z-1828-2012 | Device Design | On November 3, 2011 Biomet 3i, Palm Beach Gardens, FL initiated a recall of their Osseotite Certain Implant, Model # IOSM313, Lot #2010111529. Dental implant lot may not have an internal thread. |
The 5 latest of 10 recalls; the web page lists all.
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 61 ancestors have a recall of any class.
- Of its descendants, K170588 (Terrats Medical SL, 2017) has gone furthest, with 86 descendants of its own.
- 8 other devices also cite its predicate K874590.
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 restorations and in partially or fully edentulous spans with multiple single teeth, or as a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.
In addition, when a minimum of 4 implants, > 10mm 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/K063341 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063341: 3I Osseotite Certain Dental Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063341
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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