510(k) · Cleared
ClearedEBI External Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ebi, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Mar 27, 2015 as substantially equivalent to K073116 (Ebi, Inc., 2008) and 3 other predicates after a 210-day review. Its family tree reaches back 12 generations to 1993.
- Decided
- Mar 27, 2015
- Review
- 210 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 12 generations to K925765 (1993). 99 ancestors in all, the oldest K781060 (1978). No later device cites it as a predicate yet.
- Root · 12 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 8 generations between
- 3 generations backK062636 Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain…Implant Innovations, Inc. · 2007
- 2 generations backK100724 Osseotite II Model XifossxxxBiomet 3i, Inc. · 2011 · Recalled
- 1 generation backK111216 Osseotite 2 Dental ImplantsBiomet 3i, Inc. · 2011
- This deviceK142426 EBI External Implant SystemEbi, Inc. · 2015
Show all 12 generations
- Root · 12 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 11 generations backK994376 Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating…Friadent GmbH · 2000
- 10 generations backK014235 Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 2002
- 9 generations backK022009 3I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc. · 2002
- 8 generations backK031475 Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2003
- 7 generations backK041402 Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004
- 6 generations backK051189 Prevail Dental ImplantsImplant Innovations, Inc. · 2005
- 5 generations backK051461 3I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005
- 4 generations backK062432 Nanotite Dental ImplantsImplant Innovations, Inc. · 2007
- 3 generations backK062636 Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain…Implant Innovations, Inc. · 2007
- 2 generations backK100724 Osseotite II Model XifossxxxBiomet 3i, Inc. · 2011 · Recalled
- 1 generation backK111216 Osseotite 2 Dental ImplantsBiomet 3i, Inc. · 2011
- This deviceK142426 EBI External Implant SystemEbi, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K925765 | Branemark System Standard 3.75MM Fixture | Nobelpharma USA, Inc. | 1993 | — |
| −11 | K994376 | Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2… | Friadent GmbH | 2000 | — |
| −10 | K014235 | Osseotite NT Dental Implants & Accessories | Implant Innovations, Inc. | 2002 | — |
| −9 | K022009 | 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants | Implant Innovations, Inc. | 2002 | — |
| −8 | K031475 | Osseotite NT Certain Implants | Implant Innovations, Inc. | 2003 | — |
| −7 | K041402 | Modification to Osseotite NT Certain Implants | Implant Innovations, Inc. | 2004 | — |
| −6 | K051189 | Prevail Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −5 | K051461 | 3I Osseotite Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −4 | K062432 | Nanotite Dental Implants | Implant Innovations, Inc. | 2007 | — |
| −3 | K062636 | Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain Prevail, XP… | Implant Innovations, Inc. | 2007 | — |
| −2 | K100724 | Osseotite II Model Xifossxxx | Biomet 3i, Inc. | 2011 | 5 |
| −1 | K111216 | Osseotite 2 Dental Implants | Biomet 3i, Inc. | 2011 | — |
| 0 (this device) | K142426 | EBI External Implant System | Ebi, Inc. | 2015 | — |
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 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 9 | 0 |
| 1994 | 8 | 0 |
| 1995 | 8 | 0 |
| 1996 | 8 | 0 |
| 1997 | 5 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 5 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 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? (4)
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 |
|---|---|---|---|
| * | K073116 | Ebi Internal Implant SystemSummary page 5…4801:2007 under the worst case scenario. Predicate Devices: The subject device is substantially equivalent to the following predicate devices: K073116, EBI Internal Implant System manufactured by EBI, Inc. K111216, OSSEOTITE2 Dental Implants manufactured by BIOMET 3… | 2008 |
| * | K111216 | Osseotite 2 Dental ImplantsSummary page 5…ubject device is substantially equivalent to the following predicate devices: K073116, EBI Internal Implant System manufactured by EBI, Inc. K111216, OSSEOTITE2 Dental Implants manufactured by BIOMET 3I, Inc. K063286, OSSEOTITE; OSSEOTITE NT; XP; TG; OSSEOTITE man… | 2011 |
| * | K063286 | Osseotite; Osseotite NT; XP; TG OsseotiteSummary page 5… K073116, EBI Internal Implant System manufactured by EBI, Inc. K111216, OSSEOTITE2 Dental Implants manufactured by BIOMET 3I, Inc. K063286, OSSEOTITE; OSSEOTITE NT; XP; TG; OSSEOTITE manufactured by Implant innovations inc. K052369, Exfeel… | 2007 |
| * | K052369 | Exfeel Implant SystemSummary page 5…ts manufactured by BIOMET 3I, Inc. K063286, OSSEOTITE; OSSEOTITE NT; XP; TG; OSSEOTITE manufactured by Implant innovations inc. K052369, Exfeel Implant System manufactured by Megagen Implant Co., Ltd. Comparison to Predicate Devices: Subjec… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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 22 years and passes through 5 companies; a new generation was cleared every 12 months on median.
- 12 of the 99 ancestors have a recall of any class.
- 1 other device also cites its predicate K073116.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
EBI Dental Implant System is intended for immediate, delayed, or conventional placement in the maxillary and/or mandibular arches to support crowns, bridges, or overdentures in edentulous or partially edentulous patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142426 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142426: EBI External Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142426
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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