510(k) · Cleared
ClearedMIS V3 Conical Connection 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 May 26, 2017 as substantially equivalent to K101732 (Astra Tech AB, 2011) after a 178-day review. Its family tree reaches back 9 generations to 1990. 8 later devices descend from it.
- Decided
- May 26, 2017
- Review
- 178 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K894595 (1990). 25 ancestors in all. 8 later devices descend from it, 4 citing it directly.
- Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 5 generations between
- 3 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 2 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- 1 generation backK101732 Astra Tech Implant SystemAstra Tech AB · 2011
- This deviceK163349 MIS V3 Conical Connection Dental Implant SystemMis Implants Technologies, Ltd. · 2017
- Descendant · cites it directly · 4 of its ownK172505 MIS C1 Narrow Platform Conical Connection Implant System, MIS C1…Mis Implants Technologies, Ltd. · 2017
- Descendant · 2 generations on · 2 of its ownK241692 MIS LYNX Conical Connection Implant SystemDentsply Sirona, Inc. · 2024
- Descendant · cites it directly · 1 of its ownK173326 MIS CONNECT Conical Connection AbutmentMis Implants Technologies, Ltd. · 2018
- Descendant · 3 generations on · 0 of its ownK251647 MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant…Dentsply Sirona, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK251297 MIS LYNX Conical Connection Implant SystemDentsply Sirona, Inc. · 2025
Show all 9 generations
- Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 8 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 7 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 6 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 5 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 4 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 3 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 2 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- 1 generation backK101732 Astra Tech Implant SystemAstra Tech AB · 2011
- This deviceK163349 MIS V3 Conical Connection Dental Implant SystemMis Implants Technologies, Ltd. · 2017
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K172505MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical…Mis Implants Technologies, Ltd. · 2017 · cites it directly4descendants
- K241692MIS LYNX Conical Connection Implant SystemDentsply Sirona, Inc. · 2024 · 2 generations on2descendants
- K173326MIS CONNECT Conical Connection AbutmentMis Implants Technologies, Ltd. · 2018 · cites it directly1descendant
- K251647MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+…Dentsply Sirona, Inc. · 2025 · 3 generations on0descendants
- K251297MIS LYNX Conical Connection Implant SystemDentsply Sirona, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −8 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −7 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −6 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −5 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −4 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −3 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −2 | K071370 | Nobelactive Internal Connection Implant | Nobel Biocare AB | 2007 | 4 |
| −1 | K101732 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| 0 (this device) | K163349 | MIS V3 Conical Connection Dental Implant System | Mis Implants Technologies, Ltd. | 2017 | — |
| +1 | K172505 | MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform… | Mis Implants Technologies, Ltd. | 2017 | — |
| +2 | K241692 | MIS LYNX Conical Connection Implant System | Dentsply Sirona, Inc. | 2024 | — |
| +1 | K173326 | MIS CONNECT Conical Connection Abutment | Mis Implants Technologies, Ltd. | 2018 | — |
| +3 | K251647 | MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS… | Dentsply Sirona, Inc. | 2025 | — |
| +3 | K251297 | MIS LYNX Conical Connection Implant System | Dentsply Sirona, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2002 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K101732 | Astra Tech Implant SystemSummary page 4…n Panel: Dental Devices Panel 4. Predicate Device(s) Primary predicate device: • ASTRA TECH OsseoSpeed TX S from Astra Tech AB cleared under 510(k) K101732 Reference devices: • MIS Conical Connection Implants from MIS Implants Technologies cleared under 510(k)… | 2011 |
| † | K112162 | Conical Connection Implants | 2012 |
| † | K140347 | Ankylos C/X Implant System | 2014 |
| † | K071370 | Nobelactive Internal Connection Implant | 2007 |
| † | K102467 | Uta and Uha | 2011 |
| † | K061477 | Multi-Unit Abutments for Astratech, Camlog and Ankylos Implant Systems | 2006 |
What descends from it? (8)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 27 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 5 of the 25 ancestors have a recall of any class.
- Of its descendants, K172505 (Mis Implants Technologies, Ltd., 2017) has gone furthest, with 4 descendants of its own.
- 10 other devices also cite its predicate K101732.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 V3 Conical Connection Dental Implant System is 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…
Read the full statement (131 words)
MIS V3 Conical Connection Dental Implant System is 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, in order to restore the patient chewing function. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163349 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163349: MIS V3 Conical Connection Dental Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163349
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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