510(k) · Cleared
ClearedMIS Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Sirona, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Dec 11, 2019 as substantially equivalent to K180282 (Mis Implants Technologies, Ltd., 2018) and 1 other predicate after a 124-day review. Its family tree reaches back 10 generations to 1993. 1 later device descends from it.
- Decided
- Dec 11, 2019
- Review
- 124 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K925765 (1993). 70 ancestors in all, the oldest K781060 (1978). 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 6 generations between
- 3 generations backK051461 3I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005
- 2 generations backK063341 3I Osseotite Certain Dental ImplantsImplant Innovations, Inc. · 2007 · Recalled
- 1 generation backK180282 MIS Internal Hex Dental Implant SystemMis Implants Technologies, Ltd. · 2018
- This deviceK192149 MIS Dental Implant SystemDentsply Sirona, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK210886 MIS Lance+ Conical Connection Dental Implant SystemDentsply Sirona · 2021
Show all 10 generations
- Root · 10 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 9 generations backK994376 Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating…Friadent GmbH · 2000
- 8 generations backK014235 Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 2002
- 7 generations backK022009 3I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc. · 2002
- 6 generations backK031475 Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2003
- 5 generations backK041402 Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004
- 4 generations backK051189 Prevail Dental ImplantsImplant Innovations, Inc. · 2005
- 3 generations backK051461 3I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005
- 2 generations backK063341 3I Osseotite Certain Dental ImplantsImplant Innovations, Inc. · 2007 · Recalled
- 1 generation backK180282 MIS Internal Hex Dental Implant SystemMis Implants Technologies, Ltd. · 2018
- This deviceK192149 MIS Dental Implant SystemDentsply Sirona, Inc. · 2019
Most influential descendants
Showing 1 of 1 · See all- K210886MIS Lance+ Conical Connection Dental Implant SystemDentsply Sirona · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K925765 | Branemark System Standard 3.75MM Fixture | Nobelpharma USA, Inc. | 1993 | — |
| −9 | K994376 | Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2… | Friadent GmbH | 2000 | — |
| −8 | K014235 | Osseotite NT Dental Implants & Accessories | Implant Innovations, Inc. | 2002 | — |
| −7 | K022009 | 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants | Implant Innovations, Inc. | 2002 | — |
| −6 | K031475 | Osseotite NT Certain Implants | Implant Innovations, Inc. | 2003 | — |
| −5 | K041402 | Modification to Osseotite NT Certain Implants | Implant Innovations, Inc. | 2004 | — |
| −4 | K051189 | Prevail Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −3 | K051461 | 3I Osseotite Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −2 | K063341 | 3I Osseotite Certain Dental Implants | Implant Innovations, Inc. | 2007 | 10 |
| −1 | K180282 | MIS Internal Hex Dental Implant System | Mis Implants Technologies, Ltd. | 2018 | — |
| 0 (this device) | K192149 | MIS Dental Implant System | Dentsply Sirona, Inc. | 2019 | — |
| +1 | K210886 | MIS Lance+ Conical Connection Dental Implant System | Dentsply Sirona | 2021 | — |
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 |
|---|---|---|
| 2021 | 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 |
|---|---|---|---|
| * | K180282 | MIS Internal Hex Dental Implant SystemSummary page 4…Internal Hex Cobalt Chrome Abutments are: Primary Predicate Device 510(k) Manufacturer Implants- MIS Internal Hex K180282 MIS Implants Technologies Ltd. Dental Implant System Reference Devices 510(k)… | 2018 |
| * | K040807 | Mis Dental Implant SystemSummary page 4…echnologies Ltd. Dental Implant System Reference Devices 510(k) Manufacturer Implants and Abutments- MIS K040807 MIS Implants Technologies Ltd. Dental Implant System Abutments- Dentum Implantium/ K160828… | 2004 |
| † | K160828 | Dentium Implantium & SuperLine Prosthetics | 2016 |
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 |
|---|---|---|---|
| K210886 | MIS Lance+ Conical Connection Dental Implant System | 2021 | 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 26 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 9 of the 70 ancestors have a recall of any class.
- Of its descendants, K210886 (Dentsply Sirona, 2021) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K180282.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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) are indicated for use in surgical and restorative…
Read the full statement (155 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) 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. MIS short implants are indicated for delayed loading only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192149 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192149: MIS 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/K192149
Report an extraction error
Are you the manufacturer?
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