510(k) · Cleared
ClearedMIS Internal Hex Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mis Implants Technologies, Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Jun 22, 2018 as substantially equivalent to K040807 (Mis - Implant Technologies, Ltd., 2004) and 3 other predicates after a 142-day review. Its family tree reaches back 9 generations to 1993. 11 later devices descend from it.
- Decided
- Jun 22, 2018
- Review
- 142 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K925765 (1993). 69 ancestors in all, the oldest K781060 (1978). 11 later devices descend from it, 7 citing it directly.
- Root · 9 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 5 generations between
- 3 generations backK051189 Prevail Dental ImplantsImplant Innovations, Inc. · 2005
- 2 generations backK051461 3I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005
- 1 generation backK063341 3I Osseotite Certain Dental ImplantsImplant Innovations, Inc. · 2007 · Recalled
- This deviceK180282 MIS Internal Hex Dental Implant SystemMis Implants Technologies, Ltd. · 2018
- Descendant · cites it directly · 2 of its ownK183024 Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2020
- Descendant · cites it directly · 1 of its ownK213576 Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical · 2022
- Descendant · cites it directly · 1 of its ownK192149 MIS Dental Implant SystemDentsply Sirona, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK254145 Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC · 2026
- Descendant · cites it directly · 0 of its ownK222457 Provata Implant SystemSouthern Implants (Pty), Ltd. · 2023
Show all 9 generations
- Root · 9 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 8 generations backK994376 Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating…Friadent GmbH · 2000
- 7 generations backK014235 Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 2002
- 6 generations backK022009 3I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc. · 2002
- 5 generations backK031475 Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2003
- 4 generations backK041402 Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004
- 3 generations backK051189 Prevail Dental ImplantsImplant Innovations, Inc. · 2005
- 2 generations backK051461 3I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005
- 1 generation backK063341 3I Osseotite Certain Dental ImplantsImplant Innovations, Inc. · 2007 · Recalled
- This deviceK180282 MIS Internal Hex Dental Implant SystemMis Implants Technologies, Ltd. · 2018
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2020 · cites it directly2descendants
- K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical · 2022 · cites it directly1descendant
- K192149MIS Dental Implant SystemDentsply Sirona, Inc. · 2019 · cites it directly1descendant
- K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC · 2026 · 2 generations on0descendants
- K222457Provata Implant SystemSouthern Implants (Pty), Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K925765 | Branemark System Standard 3.75MM Fixture | Nobelpharma USA, Inc. | 1993 | — |
| −8 | K994376 | Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2… | Friadent GmbH | 2000 | — |
| −7 | K014235 | Osseotite NT Dental Implants & Accessories | Implant Innovations, Inc. | 2002 | — |
| −6 | K022009 | 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants | Implant Innovations, Inc. | 2002 | — |
| −5 | K031475 | Osseotite NT Certain Implants | Implant Innovations, Inc. | 2003 | — |
| −4 | K041402 | Modification to Osseotite NT Certain Implants | Implant Innovations, Inc. | 2004 | — |
| −3 | K051189 | Prevail Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −2 | K051461 | 3I Osseotite Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −1 | K063341 | 3I Osseotite Certain Dental Implants | Implant Innovations, Inc. | 2007 | 10 |
| 0 (this device) | K180282 | MIS Internal Hex Dental Implant System | Mis Implants Technologies, Ltd. | 2018 | — |
| +1 | K183024 | Implacil Implant System | Implacil DE Bortoli Material Odontologico Ltda | 2020 | — |
| +1 | K213576 | Tatum Surgical Dental Implant System | Suncoast Dental, Inc. Dba Tatum Surgical | 2022 | — |
| +1 | K192149 | MIS Dental Implant System | Dentsply Sirona, Inc. | 2019 | — |
| +2 | K254145 | Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™) | Smart Denture Conversions, LLC | 2026 | — |
| +1 | K222457 | Provata Implant System | Southern Implants (Pty), Ltd. | 2023 | — |
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 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 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? (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 |
|---|---|---|---|
| * | K040807 | Mis Dental Implant SystemSummary page 4…Class II Classification Panel: Dental Devices Panel 4. Predicate Device(s) Primary predicate device: MIS Dental Implant System cleared under 510(k) K040807. Reference devices: • MIS Short Implants K103089 • Xive S plus Dental Implant System K073075 • MIS V3… | 2004 |
| * | K073075 | Frialit Plus, Xive S Plus, Xive TG Plus, Ankylos Plus, Dental Implant SystemsSummary page 4…e device: MIS Dental Implant System cleared under 510(k) K040807. Reference devices: • MIS Short Implants K103089 • Xive S plus Dental Implant System K073075 • MIS V3 Conical Connection Dental implant System K163349 • 3i OSSEOTITE Certain Dental Implants K063341… | 2008 |
| * | K103089 | Seven Implants; Biocom Implants; Lance ImplantsSummary page 4…s Panel 4. Predicate Device(s) Primary predicate device: MIS Dental Implant System cleared under 510(k) K040807. Reference devices: • MIS Short Implants K103089 • Xive S plus Dental Implant System K073075 • MIS V3 Conical Connection Dental implant System K163349 • 3… | 2011 |
| * | K063341 | 3I Osseotite Certain Dental ImplantsSummary page 4…3089 • Xive S plus Dental Implant System K073075 • MIS V3 Conical Connection Dental implant System K163349 • 3i OSSEOTITE Certain Dental Implants K063341 • K160828 Dentium Implantium & SuperLine Prosthetics Device Description The MIS internal hex implant system includes two… | 2007 |
| † | K163349 | MIS V3 Conical Connection Dental Implant System | 2017 |
| † | K160828 | Dentium Implantium & SuperLine Prosthetics | 2016 |
What descends from it? (11)
See all 117 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183024 | Implacil Implant System | 2020 | 2 |
| K213576 | Tatum Surgical Dental Implant System | 2022 | 1 |
| K192149 | MIS Dental Implant System | 2019 | 1 |
| K222457 | Provata Implant System | 2023 | 0 |
| K221910 | QRS Dental Implants System | 2022 | 0 |
| K200102 | MIS Dental Implant System | 2020 | 0 |
| K182228 | MIS LOCKiT Abutments System, OT-Equators and Ball Attachments | 2019 | 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 25 years and passes through 4 companies; a new generation was cleared every 12 months on median.
- 9 of the 69 ancestors have a recall of any class.
- Of its descendants, K183024 (Implacil DE Bortoli Material Odontologico Ltda, 2020) has gone furthest, with 2 descendants of its own.
- 21 other devices also cite its predicate K040807.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
MIS dental implant systems are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate. Narrow implants (Ø3.3mm & UNO) are indicated for use in surgical and…
Read the full statement (157 words)
MIS dental implant systems are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate.
Narrow implants (Ø3.3mm & UNO) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.
The long MIS (18 & 20 mm) implants can be used in a tilted manner.
MIS short implants are to be used only with straight abutments.
M4 short implants are indicated for delayed loading only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180282 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180282: MIS Internal Hex Dental 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/K180282
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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