510(k) · Cleared
ClearedMIS Lance+ Conical Connection Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Sirona · DZE Implant, Endosseous, Root-Form
Cleared on Jun 17, 2021 as substantially equivalent to K192149 (Dentsply Sirona, Inc., 2019) after an 84-day review. Its family tree reaches back 11 generations to 1993.
- Decided
- Jun 17, 2021
- Review
- 84 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K925765 (1993). 71 ancestors in all, the oldest K781060 (1978). No later device cites it as a predicate yet.
- Root · 11 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 7 generations between
- 3 generations backK063341 3I Osseotite Certain Dental ImplantsImplant Innovations, Inc. · 2007 · Recalled
- 2 generations backK180282 MIS Internal Hex Dental Implant SystemMis Implants Technologies, Ltd. · 2018
- 1 generation backK192149 MIS Dental Implant SystemDentsply Sirona, Inc. · 2019
- This deviceK210886 MIS Lance+ Conical Connection Dental Implant SystemDentsply Sirona · 2021
Show all 11 generations
- Root · 11 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 10 generations backK994376 Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating…Friadent GmbH · 2000
- 9 generations backK014235 Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 2002
- 8 generations backK022009 3I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc. · 2002
- 7 generations backK031475 Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2003
- 6 generations backK041402 Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004
- 5 generations backK051189 Prevail Dental ImplantsImplant Innovations, Inc. · 2005
- 4 generations backK051461 3I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005
- 3 generations backK063341 3I Osseotite Certain Dental ImplantsImplant Innovations, Inc. · 2007 · Recalled
- 2 generations backK180282 MIS Internal Hex Dental Implant SystemMis Implants Technologies, Ltd. · 2018
- 1 generation backK192149 MIS Dental Implant SystemDentsply Sirona, Inc. · 2019
- This deviceK210886 MIS Lance+ Conical Connection Dental Implant SystemDentsply Sirona · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K925765 | Branemark System Standard 3.75MM Fixture | Nobelpharma USA, Inc. | 1993 | — |
| −10 | K994376 | Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2… | Friadent GmbH | 2000 | — |
| −9 | K014235 | Osseotite NT Dental Implants & Accessories | Implant Innovations, Inc. | 2002 | — |
| −8 | K022009 | 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants | Implant Innovations, Inc. | 2002 | — |
| −7 | K031475 | Osseotite NT Certain Implants | Implant Innovations, Inc. | 2003 | — |
| −6 | K041402 | Modification to Osseotite NT Certain Implants | Implant Innovations, Inc. | 2004 | — |
| −5 | K051189 | Prevail Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −4 | K051461 | 3I Osseotite Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −3 | K063341 | 3I Osseotite Certain Dental Implants | Implant Innovations, Inc. | 2007 | 10 |
| −2 | K180282 | MIS Internal Hex Dental Implant System | Mis Implants Technologies, Ltd. | 2018 | — |
| −1 | K192149 | MIS Dental Implant System | Dentsply Sirona, Inc. | 2019 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K192149 | MIS Dental Implant SystemSummary page 4…the substantial equivalence of the proposed MIS Lance+ Conical Connection Implants entailing a modification of the MIS Lance+ Internal Hex Dental Implant System (K192149) with the conical connection of the MIS C1 Conical Connection Dental Implant System (K172505 for C1 Narrow platform implants… | 2019 |
| † | K172505 | MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical… | 2017 |
| † | K112162 | Conical Connection Implants | 2012 |
| † | K200102 | MIS Dental Implant System | 2020 |
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 28 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 9 of the 71 ancestors have 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. 2021, 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 System is intended to be surgically placed in the bone of the upper and lower jaw arches to provide support for prosthetic device, 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 in appropriate. Narrow implants (@3.3mm) are indicated for use in surgical and restorative…
Read the full statement (120 words)
MIS Dental Implant System is intended to be surgically placed in the bone of the upper and lower jaw arches to provide
support for prosthetic device, 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 in appropriate.
Narrow implants (@3.3mm) 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K210886 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210886: MIS Lance+ Conical Connection 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/K210886
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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