510(k) · Cleared
ClearedHaptite Coating Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentis Co., Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Feb 1, 2012 as substantially equivalent to K073070 (Dio Department Dsi, Inc., 2008) and 1 other predicate after a 261-day review. Its family tree reaches back 4 generations to 1993. 1 later device descends from it.
- Decided
- Feb 1, 2012
- Review
- 261 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K911592 (1993). 18 ancestors in all, the oldest K852765 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK911592 Steri-Oss Titanium Plama Spray Cylindrical ImplantSteri-Oss, Inc. · 1993
- 3 generations backK973423 Steri-Oss 3.25 MM Replace (Hydroxyapatite-Coated)Dental ImplantSteri-Oss, Inc. · 1997
- 2 generations backK020646 Replace HA Coated Implant, Models 35102, 35132, 35162, 43102, 43132…Nobel Biocare Uas, Inc. · 2002
- 1 generation backK022424 Replace HA Coated Implant, Models 35102, 35132, 35162, 43102, 43132…Nobel Biocare Uas, Inc. · 2002
- This deviceK111364 Haptite Coating Implant SystemDentis Co., Ltd. · 2012
- Descendant · cites it directly · 0 of its ownK173938 IS-III HActive FixtureNeobiotech Co., Ltd. · 2018
Most influential descendants
Showing 1 of 1 · See all- K173938IS-III HActive FixtureNeobiotech Co., Ltd. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K911592 | Steri-Oss Titanium Plama Spray Cylindrical Implant | Steri-Oss, Inc. | 1993 | — |
| −3 | K973423 | Steri-Oss 3.25 MM Replace (Hydroxyapatite-Coated)Dental Implant | Steri-Oss, Inc. | 1997 | — |
| −2 | K020646 | Replace HA Coated Implant, Models 35102, 35132, 35162, 43102, 43132, 43162… | Nobel Biocare Uas, Inc. | 2002 | — |
| −1 | K022424 | Replace HA Coated Implant, Models 35102, 35132, 35162, 43102, 43132, 43162… | Nobel Biocare Uas, Inc. | 2002 | — |
| 0 (this device) | K111364 | Haptite Coating Implant System | Dentis Co., Ltd. | 2012 | — |
| +1 | K173938 | IS-III HActive Fixture | Neobiotech Co., Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 3 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 |
|---|---|---|---|
| * | K073070 | Dio Biotite-H Implant SystemSummary page 2…es & Comparison The subject device is substantially equivalent to the following predicate device: * DIG BIOTITE-H IMPLANT SYSTEM manufacture by DIG Deparment, DSI (K073070) * Replace HA coated implant manufactured by Nobel Biocare USA, INC. (K022424) Testing and other comparisons have establish… | 2008 |
| * | K022424 | Replace HA Coated Implant, Models 35102, 35132, 35162, 43102, 43132, 43162, 50102…Summary page 2…dicate device: * DIG BIOTITE-H IMPLANT SYSTEM manufacture by DIG Deparment, DSI (K073070) * Replace HA coated implant manufactured by Nobel Biocare USA, INC. (K022424) Testing and other comparisons have established that the subject of HAPTITE implant system is substantially equivalent in design… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173938 | IS-III HActive Fixture | 2018 | 0 |
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 19 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
- None of the 18 ancestors has a recall.
- Of its descendants, K173938 (Neobiotech Co., Ltd., 2018) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K073070.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 HAPTITh Coating Implant System is indicated for use in partially or fully edentulous mandibles and
maxillae, in support of single or multiple-unit restorations including; cemented retained, screw
retained, or overdenture restorations, and terminal or intermediate abutment support for fixed
bridgework. This system is dedicated for one and two stage surgical procedures and not dedicated
for immediate loading. This system is intended for delayed loading
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111364 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111364: Haptite Coating 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/K111364
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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