510(k) · Cleared
Recalled · Class II · 2014Osseotite II Model Xifossxxx
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet 3i, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Apr 1, 2011 as substantially equivalent to K063341 (Implant Innovations, Inc., 2007) and 2 other predicates after a 382-day review. Its family tree reaches back 10 generations to 1993. 27 later devices descend from it. It has been recalled 5 times.
- Decided
- Apr 1, 2011
- Review
- 382 days
- Class
- Class II
- Product code
- DZE
- Recalls
- 5
- Predicates
- 3
Its longest line of descent runs back 10 generations to K925765 (1993). 66 ancestors in all, the oldest K781060 (1978). 27 later devices descend from it, 4 citing it directly.
- Root · 10 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 6 generations between
- 3 generations backK051461 3I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005
- 2 generations backK062432 Nanotite Dental ImplantsImplant Innovations, Inc. · 2007
- 1 generation backK062636 Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain…Implant Innovations, Inc. · 2007
- This deviceK100724 Osseotite II Model XifossxxxBiomet 3i, Inc. · 2011
- Descendant · cites it directly · 22 of its ownK122300 T3 Dental ImplantBiomet 3i · 2013 · Recalled
- Descendant · cites it directly · 21 of its ownK111216 Osseotite 2 Dental ImplantsBiomet 3i, Inc. · 2011
- Descendant · 2 generations on · 19 of its ownK133049 3I T3(R) External Hex Dental ImplantsBiomet 3i · 2014
- Descendant · 3 generations on · 13 of its ownK163634 External Hex ImplantsSouthern Implants (Pty), Ltd. · 2017 · Recalled
- Descendant · 4 generations on · 3 of its ownK193084 TIB Abutment SystemSouthern Implants (Pty), Ltd. · 2020
Show all 10 generations
- Root · 10 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 9 generations backK994376 Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating…Friadent GmbH · 2000
- 8 generations backK014235 Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 2002
- 7 generations backK022009 3I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc. · 2002
- 6 generations backK031475 Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2003
- 5 generations backK041402 Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004
- 4 generations backK051189 Prevail Dental ImplantsImplant Innovations, Inc. · 2005
- 3 generations backK051461 3I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005
- 2 generations backK062432 Nanotite Dental ImplantsImplant Innovations, Inc. · 2007
- 1 generation backK062636 Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain…Implant Innovations, Inc. · 2007
- This deviceK100724 Osseotite II Model XifossxxxBiomet 3i, Inc. · 2011
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K122300T3 Dental ImplantBiomet 3i · 2013 · cites it directly22descendants
- K111216Osseotite 2 Dental ImplantsBiomet 3i, Inc. · 2011 · cites it directly21descendants
- K1330493I T3(R) External Hex Dental ImplantsBiomet 3i · 2014 · 2 generations on19descendants
- K163634External Hex ImplantsSouthern Implants (Pty), Ltd. · 2017 · 3 generations on13descendants
- K193084TIB Abutment SystemSouthern Implants (Pty), Ltd. · 2020 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K925765 | Branemark System Standard 3.75MM Fixture | Nobelpharma USA, Inc. | 1993 | — |
| −9 | K994376 | Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2… | Friadent GmbH | 2000 | — |
| −8 | K014235 | Osseotite NT Dental Implants & Accessories | Implant Innovations, Inc. | 2002 | — |
| −7 | K022009 | 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants | Implant Innovations, Inc. | 2002 | — |
| −6 | K031475 | Osseotite NT Certain Implants | Implant Innovations, Inc. | 2003 | — |
| −5 | K041402 | Modification to Osseotite NT Certain Implants | Implant Innovations, Inc. | 2004 | — |
| −4 | K051189 | Prevail Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −3 | K051461 | 3I Osseotite Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −2 | K062432 | Nanotite Dental Implants | Implant Innovations, Inc. | 2007 | — |
| −1 | K062636 | Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain Prevail, XP… | Implant Innovations, Inc. | 2007 | — |
| 0 (this device) | K100724 | Osseotite II Model Xifossxxx | Biomet 3i, Inc. | 2011 | — |
| +1 | K122300 | T3 Dental Implant | Biomet 3i | 2013 | 3 |
| +1 | K111216 | Osseotite 2 Dental Implants | Biomet 3i, Inc. | 2011 | — |
| +2 | K133049 | 3I T3(R) External Hex Dental Implants | Biomet 3i | 2014 | — |
| +3 | K163634 | External Hex Implants | Southern Implants (Pty), Ltd. | 2017 | 1 |
| +4 | K193084 | TIB Abutment System | Southern Implants (Pty), Ltd. | 2020 | — |
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 | 3 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 5 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 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 |
|---|---|---|---|
| * | K063341 | 3I Osseotite Certain Dental ImplantsSummary page 1…Dental Implant Classification Name: Endosseous Dental Implant Device Classification/Code: Class 11 - 21 CFR §872.3640 / DZE Predicate Devices: K063341 BIOMET 3i OSSEOTITEO Dental Implant System K062636 BIOMET 3i Dental Implants Indications for Use: BIOM… | 2007 |
| * | K062636 | Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain Prevail, XP…Summary page 1…mplant Device Classification/Code: Class 11 - 21 CFR §872.3640 / DZE Predicate Devices: K063341 BIOMET 3i OSSEOTITEO Dental Implant System K062636 BIOMET 3i Dental Implants Indications for Use: BIOMET 3i Dental Implants are intended for surgical placement in… | 2007 |
| * | K063286 | Osseotite; Osseotite NT; XP; TG OsseotiteSummary page 1…ental Implants are substantially equivalent to BIOMET 3i's OSSEOTITE® Dental Implants which have been previously cleared in K063286 and K063341. 5 of 91 Technological… | 2007 |
What descends from it? (27)
See all 274 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 7, 2014 | Class II | Z-1410-2015 | Manufacturing material removal | Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored. |
| Jun 10, 2013 | Class II | Z-2207-2013 | 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. |
| Sep 28, 2012 | Class II | Z-0297-2013 | Nonconforming Material/Component | Biomet 3i recalled Full OSSEOTITE 2 Tapered Certain Implant and Full OSSEOTITE Parallel Walled Certain Implant due to a manufacturing condition where the depth of the implant's internal hex is too shallow. This condition may prevent the… |
| Sep 28, 2012 | Class II | Z-0298-2013 | Nonconforming Material/Component | Biomet 3i recalled Full OSSEOTITE 2 Tapered Certain Implant and Full OSSEOTITE Parallel Walled Certain Implant due to a manufacturing condition where the depth of the implant's internal hex is too shallow. This condition may prevent the… |
| Nov 18, 2010 | Not classified | Z-0171-2012 | Process control | The product may contain a manufacturing defect, that if present, may prevent the driver; cover screw or abutment from fully engaging the implant. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 12 months on median.
- 10 of the 66 ancestors have a recall of any class.
- Of its descendants, K122300 (Biomet 3i, 2013) has gone furthest, with 22 descendants of its own.
- 14 other devices also cite its predicate K063341.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
BIOMET 3i Dental Implants are intended for surgical placement in either jaw and used for anchoring or supporting single- and multiple-unit prostheses. BIOMET 3i Dental Implants can be immediately loaded when primary stability and proper occlusion have been established.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100724 · printed Nov 3, 2026
Cite this page
510(k) Report. “K100724: Osseotite II Model Xifossxxx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K100724
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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