510(k) · Cleared
ClearedOsseotite 2 Dental Implants
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 Nov 18, 2011 as substantially equivalent to K100724 (Biomet 3i, Inc., 2011) and 1 other predicate after a 200-day review. Its family tree reaches back 11 generations to 1993. 21 later devices descend from it.
- Decided
- Nov 18, 2011
- Review
- 200 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K925765 (1993). 67 ancestors in all, the oldest K781060 (1978). 21 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 7 generations between
- 3 generations backK062432 Nanotite Dental ImplantsImplant Innovations, Inc. · 2007
- 2 generations backK062636 Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain…Implant Innovations, Inc. · 2007
- 1 generation backK100724 Osseotite II Model XifossxxxBiomet 3i, Inc. · 2011 · Recalled
- This deviceK111216 Osseotite 2 Dental ImplantsBiomet 3i, Inc. · 2011
- Descendant · cites it directly · 19 of its ownK133049 3I T3(R) External Hex Dental ImplantsBiomet 3i · 2014
- Descendant · 2 generations on · 13 of its ownK163634 External Hex ImplantsSouthern Implants (Pty), Ltd. · 2017 · Recalled
- Descendant · 3 generations on · 3 of its ownK193084 TIB Abutment SystemSouthern Implants (Pty), Ltd. · 2020
- Descendant · 3 generations on · 2 of its ownK183024 Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2020
- Descendant · 3 generations on · 2 of its ownK180465 Provata Implant SystemSouthern Implants (Pty), Ltd. · 2018
Show all 11 generations
- Root · 11 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 10 generations backK994376 Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating…Friadent GmbH · 2000
- 9 generations backK014235 Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 2002
- 8 generations backK022009 3I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc. · 2002
- 7 generations backK031475 Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2003
- 6 generations backK041402 Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004
- 5 generations backK051189 Prevail Dental ImplantsImplant Innovations, Inc. · 2005
- 4 generations backK051461 3I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005
- 3 generations backK062432 Nanotite Dental ImplantsImplant Innovations, Inc. · 2007
- 2 generations backK062636 Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain…Implant Innovations, Inc. · 2007
- 1 generation backK100724 Osseotite II Model XifossxxxBiomet 3i, Inc. · 2011 · Recalled
- This deviceK111216 Osseotite 2 Dental ImplantsBiomet 3i, Inc. · 2011
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K1330493I T3(R) External Hex Dental ImplantsBiomet 3i · 2014 · cites it directly19descendants
- K163634External Hex ImplantsSouthern Implants (Pty), Ltd. · 2017 · 2 generations on13descendants
- K193084TIB Abutment SystemSouthern Implants (Pty), Ltd. · 2020 · 3 generations on3descendants
- K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2020 · 3 generations on2descendants
- K180465Provata Implant SystemSouthern Implants (Pty), Ltd. · 2018 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K925765 | Branemark System Standard 3.75MM Fixture | Nobelpharma USA, Inc. | 1993 | — |
| −10 | K994376 | Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2… | Friadent GmbH | 2000 | — |
| −9 | K014235 | Osseotite NT Dental Implants & Accessories | Implant Innovations, Inc. | 2002 | — |
| −8 | K022009 | 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants | Implant Innovations, Inc. | 2002 | — |
| −7 | K031475 | Osseotite NT Certain Implants | Implant Innovations, Inc. | 2003 | — |
| −6 | K041402 | Modification to Osseotite NT Certain Implants | Implant Innovations, Inc. | 2004 | — |
| −5 | K051189 | Prevail Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −4 | K051461 | 3I Osseotite Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −3 | K062432 | Nanotite Dental Implants | Implant Innovations, Inc. | 2007 | — |
| −2 | K062636 | Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain Prevail, XP… | Implant Innovations, Inc. | 2007 | — |
| −1 | K100724 | Osseotite II Model Xifossxxx | Biomet 3i, Inc. | 2011 | 5 |
| 0 (this device) | K111216 | Osseotite 2 Dental Implants | Biomet 3i, Inc. | 2011 | — |
| +1 | K133049 | 3I T3(R) External Hex Dental Implants | Biomet 3i | 2014 | — |
| +2 | K163634 | External Hex Implants | Southern Implants (Pty), Ltd. | 2017 | 1 |
| +3 | K193084 | TIB Abutment System | Southern Implants (Pty), Ltd. | 2020 | — |
| +3 | K183024 | Implacil Implant System | Implacil DE Bortoli Material Odontologico Ltda | 2020 | — |
| +3 | K180465 | Provata Implant System | Southern Implants (Pty), Ltd. | 2018 | — |
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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 5 | 0 |
| 2024 | 3 | 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? (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 |
|---|---|---|---|
| * | K100724 | Osseotite II Model XifossxxxSummary page 1…/ FDA Endosseous Dental Implant / Dental Panel Reviewing Branch: Device Classification/Code: Class 11 -21 CFR §872.3640 / DZE Predicate Device K100724 - OSSEOTITE 11 MODEL XIFOSSXXX /BIOMET 3i Manufacturer: K063286 - OSSEOTITE Dental Implants / BIOMET 3i Purpo… | 2011 |
| * | K063286 | Osseotite; Osseotite NT; XP; TG OsseotiteSummary page 1…assification/Code: Class 11 -21 CFR §872.3640 / DZE Predicate Device K100724 - OSSEOTITE 11 MODEL XIFOSSXXX /BIOMET 3i Manufacturer: K063286 - OSSEOTITE Dental Implants / BIOMET 3i Purpose of the SPECIAL The reason for this Special 510k submission is to reques… | 2007 |
What descends from it? (21)
See all 212 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 18 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 11 of the 67 ancestors have a recall of any class.
- Of its descendants, K133049 (Biomet 3i, 2014) has gone furthest, with 19 descendants of its own.
- 3 other devices also cite its predicate K100724.
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 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 utilizing delayed or immediate loading, or with a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.
OSSEOTITE® 2 Dental Implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111216 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111216: Osseotite 2 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/K111216
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