510(k) · Cleared
ClearedEbi Internal 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 Feb 28, 2008 as substantially equivalent to K051576 (Osstem Co., Ltd., 2005) and 1 other predicate after a 115-day review. Its family tree reaches back 5 generations to 1990. 3 later devices descend from it.
- Decided
- Feb 28, 2008
- Review
- 115 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K894595 (1990). 16 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 4 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 3 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 2 generations backK011879 3A Dental Implant SystemOsseco Biosource, Ltd. · 2002
- 1 generation backK051576 Avana Dental Implant SystemOsstem Co., Ltd. · 2005
- This deviceK073116 Ebi Internal Implant SystemEbi, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK170031 Internal Octa Implant SystemEbi, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK190837 Internal Hex Implant SystemEbi, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK142426 EBI External Implant SystemEbi, Inc. · 2015
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −4 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −3 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −2 | K011879 | 3A Dental Implant System | Osseco Biosource, Ltd. | 2002 | — |
| −1 | K051576 | Avana Dental Implant System | Osstem Co., Ltd. | 2005 | — |
| 0 (this device) | K073116 | Ebi Internal Implant System | Ebi, Inc. | 2008 | — |
| +1 | K170031 | Internal Octa Implant System | Ebi, Inc. | 2017 | — |
| +2 | K190837 | Internal Hex Implant System | Ebi, Inc. | 2020 | — |
| +1 | K142426 | EBI External Implant System | Ebi, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K051576 | Avana Dental Implant SystemSummary page 1…Dental Devices Panel 21 CFR 872.3640 and 872.3630 Predicate Devices * AVANA Dental Implant System K051576 ilM Dental implant system K003552 Performance Performance standards have… | 2005 |
| * | K003552 | Iti Dental Implant SystemSummary page 1…21 CFR 872.3640 and 872.3630 Predicate Devices * AVANA Dental Implant System K051576 ilM Dental implant system K003552 Performance Performance standards have not been established by the FDA under Sect… | 2001 |
What descends from it? (3)
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 18 years and passes through 6 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 16 ancestors has a recall of any class.
- Of its descendants, K170031 (Ebi, Inc., 2017) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K051576.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
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/K073116 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073116: Ebi Internal Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073116
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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