510(k) · Cleared
ClearedInternal Hex 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 Jan 22, 2020 as substantially equivalent to K170031 (Ebi, Inc., 2017) after a 296-day review. Its family tree reaches back 7 generations to 1990.
- Decided
- Jan 22, 2020
- Review
- 296 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K894595 (1990). 18 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 6 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 5 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 4 generations backK011879 3A Dental Implant SystemOsseco Biosource, Ltd. · 2002
- 3 generations backK051576 Avana Dental Implant SystemOsstem Co., Ltd. · 2005
- 2 generations backK073116 Ebi Internal Implant SystemEbi, Inc. · 2008
- 1 generation backK170031 Internal Octa Implant SystemEbi, Inc. · 2017
- This deviceK190837 Internal Hex Implant SystemEbi, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −6 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −5 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −4 | K011879 | 3A Dental Implant System | Osseco Biosource, Ltd. | 2002 | — |
| −3 | K051576 | Avana Dental Implant System | Osstem Co., Ltd. | 2005 | — |
| −2 | K073116 | Ebi Internal Implant System | Ebi, Inc. | 2008 | — |
| −1 | K170031 | Internal Octa Implant System | Ebi, Inc. | 2017 | — |
| 0 (this device) | K190837 | Internal Hex Implant System | Ebi, Inc. | 2020 | — |
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 |
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? (1)
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 |
|---|---|---|---|
| * | K170031 | Internal Octa Implant SystemSummary page 4…ass II • Date Prepared: 01/21/2020 Predicate Devices: The subject device is substantially equivalent to the following predicate device: Primary Predicate • K170031, Internal Octa Implant System manufactured by EBI Inc. Reference Device • K042971, TITAN Dental Implant System by Titan… | 2017 |
| † | K042971 | Titan Dental Implant System | 2005 |
| † | K063286 | Osseotite; Osseotite NT; XP; TG Osseotite | 2007 |
| † | K073116 | Ebi Internal Implant System | 2008 |
| † | K113554 | Cmi Implant IS System | 2012 |
| † | K121585 | TS Implant System | 2013 |
| † | K140091 | Xpeed Anyridge Internal Implant Sysyem | 2014 |
| † | K142426 | EBI External Implant System | 2015 |
| † | K162099 | IBS Implant System II | 2017 |
| † | K163349 | MIS V3 Conical Connection Dental Implant System | 2017 |
| † | K181138 | IS-III active System | 2018 |
| † | K190849 | IS-III active System_S-narrow Type | 2019 |
| † | K173701 | Implant-One System | 2018 |
| † | K190552 | JJ Implant System | 2019 |
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 30 years and passes through 6 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 18 ancestors has a recall of any class.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
The Internal Hex Implant System is intended for placement in the maxillary and/or mandibular arches to support crowns, bridges, or overdentures in edentulous or partially edentulous patients. For implant bodies Ø4.1 and greater, the Internal Hex Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Implant bodies with a diameter less than Ø4.1 are intended for immediate loading when using a minimum of 4 implants with lengths >8mm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190837 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190837: Internal Hex 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/K190837
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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