510(k) · Cleared
ClearedMIS CONNECT Conical Connection System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Sirona · NHA Abutment, Implant, Dental, Endosseous
Cleared on Mar 25, 2020 as substantially equivalent to K173326 (Mis Implants Technologies, Ltd., 2018) after a 141-day review. Its family tree reaches back 11 generations to 1990.
- Decided
- Mar 25, 2020
- Review
- 141 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K894595 (1990). 27 ancestors in all. No later device cites it as a predicate yet.
- Root · 11 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 7 generations between
- 3 generations backK101732 Astra Tech Implant SystemAstra Tech AB · 2011
- 2 generations backK163349 MIS V3 Conical Connection Dental Implant SystemMis Implants Technologies, Ltd. · 2017
- 1 generation backK173326 MIS CONNECT Conical Connection AbutmentMis Implants Technologies, Ltd. · 2018
- This deviceK193078 MIS CONNECT Conical Connection SystemDentsply Sirona · 2020
Show all 11 generations
- Root · 11 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 10 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 9 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 8 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 7 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 6 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 5 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 4 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- 3 generations backK101732 Astra Tech Implant SystemAstra Tech AB · 2011
- 2 generations backK163349 MIS V3 Conical Connection Dental Implant SystemMis Implants Technologies, Ltd. · 2017
- 1 generation backK173326 MIS CONNECT Conical Connection AbutmentMis Implants Technologies, Ltd. · 2018
- This deviceK193078 MIS CONNECT Conical Connection SystemDentsply Sirona · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −10 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −9 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −8 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −7 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −6 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −5 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −4 | K071370 | Nobelactive Internal Connection Implant | Nobel Biocare AB | 2007 | 4 |
| −3 | K101732 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| −2 | K163349 | MIS V3 Conical Connection Dental Implant System | Mis Implants Technologies, Ltd. | 2017 | — |
| −1 | K173326 | MIS CONNECT Conical Connection Abutment | Mis Implants Technologies, Ltd. | 2018 | — |
| 0 (this device) | K193078 | MIS CONNECT Conical Connection System | Dentsply Sirona | 2020 | — |
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 |
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 NHA? 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 NHA device
- #1 K222288 DESS Dental Smart Solutionsscore 30.6 · 19 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 |
|---|---|---|---|
| * | K173326 | MIS CONNECT Conical Connection AbutmentSummary page 4… Product Code: NHA 3.0 Predicate Device: Primary Predicate Device Name 510(k) Company Name MIS CONNECT Conical Connection K173326 MIS Implants Technologies Ltd. abutment (Owner/Operator : Dentsply Sirona) Referen… | 2018 |
| † | K163349 | MIS V3 Conical Connection Dental Implant System | 2017 |
| † | K172505 | MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical… | 2017 |
| † | K112162 | Conical Connection Implants | 2012 |
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 30 years and passes through 7 companies; a new generation was cleared every 1.9 years on median.
- 5 of the 27 ancestors have a recall of any class.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · NHA
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NHA
147in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHA
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHA
838in 2025
MAUDE reports naming product code NHA, 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 | 38 | 91 | 1 | 1 |
| 2008 | 31 | 90 | 2 | 8 |
| 2009 | 30 | 95 | 0 | 30 |
| 2010 | 19 | 162 | 0 | 61 |
| 2011 | 31 | 130 | 5 | 56 |
| 2012 | 25 | 171 | 1 | 5 |
| 2013 | 22 | 184 | 1 | 143 |
| 2014 | 27 | 160 | 0 | 146 |
| 2015 | 29 | 151 | 1 | 858 |
| 2016 | 38 | 202 | 36 | 314 |
| 2017 | 31 | 188 | 2 | 577 |
| 2018 | 31 | 200 | 1 | 591 |
| 2019 | 28 | 160 | 0 | 530 |
| 2020 | 38 | 153 | 7 | 458 |
| 2021 | 29 | 211 | 0 | 546 |
| 2022 | 33 | 142 | 0 | 497 |
| 2023 | 51 | 147 | 3 | 618 |
| 2024 | 43 | 158 | 0 | 635 |
| 2025 | 40 | 147 | 1 | 838 |
| 2026 | 23 | 169 | 3 | — |
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 (03.3mm) are indicated for use in surgical and restorative…
Read the full statement (128 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 (03.3mm) 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/K193078 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193078: MIS CONNECT Conical Connection System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193078
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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