Data / Medical devices / Israel / MIS Implants Technologies Ltd.
MIS Implants Technologies Ltd.: FDA-registered device maker in BAR LEV INDUSTRIAL PARK Northern, Israel, 22 510(k) clearances
MIS Implants Technologies Ltd. is registered with the FDA (registration 3004203816) in BAR LEV INDUSTRIAL PARK Northern, Israel. It lists 8 device types. The FDA files 22 510(k) clearances under its listings, the newest dated February 6, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004203816
- Address
- Bar Lev Industrial Park P.o.box 7, BAR LEV INDUSTRIAL PARK Northern, Israel, 2015600
- Owner or operator
- DENTSPLY SIRONA INC (2511302)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- October 23, 2001
- Registered through
- 2026
- Brand names listed
- 4BONE BCH, Anti rotation cementing cap for connect abutment, Attachments, BondBone, C1, Coni Con Ti Base, Connect abutment, Connect abutment anti rotation temporary cylinder and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Attachment, Precision, All | EGG | 1 | Manufacturer | accessdata.fda.gov |
| Bone Grafting Material, Synthetic | LYC | 2 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Dental Abutment Design Software For Dental Laboratory | PNP | 2 | Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Orthodontic | OAT | 2 | Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Manufacturer | accessdata.fda.gov |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 6, 2026 | K251614 | Stainless Steel Surgical Kits | KCT | Substantially Equivalent | Dentsply Sirona, Inc. | accessdata.fda.gov |
| August 21, 2025 | K251647 | MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection System | DZE | Substantially Equivalent | Dentsply Sirona, Inc. | accessdata.fda.gov |
| July 24, 2025 | K251297 | MIS LYNX Conical Connection Implant System | DZE | Substantially Equivalent | Dentsply Sirona, Inc. | accessdata.fda.gov |
| July 22, 2025 | K251300 | Plastic Surgical Kits | KCT | Substantially Equivalent | Dentsply Sirona, Inc. | accessdata.fda.gov |
| November 25, 2024 | K241692 | MIS LYNX Conical Connection Implant System | DZE | Substantially Equivalent | Dentsply Sirona, Inc. | accessdata.fda.gov |
| April 1, 2022 | K213432 | MIS Angulated multi-unit abutments | NHA | Substantially Equivalent | Dentsply Sirona | accessdata.fda.gov |
| July 28, 2021 | K211225 | MIS Ti-base abutment | NHA | Substantially Equivalent | Dentsply Sirona | accessdata.fda.gov |
| June 17, 2021 | K210886 | MIS Lance+ Conical Connection Dental Implant System | DZE | Substantially Equivalent | Dentsply Sirona | accessdata.fda.gov |
| September 3, 2020 | K200102 | MIS Dental Implant System | DZE | Substantially Equivalent | Dentsply Sirona | accessdata.fda.gov |
| July 6, 2020 | K191152 | MIS Ti-base Abutment | NHA | Substantially Equivalent | Dentsply Sirona | accessdata.fda.gov |
| March 25, 2020 | K193078 | MIS CONNECT Conical Connection System | NHA | Substantially Equivalent | Dentsply Sirona | accessdata.fda.gov |
| December 11, 2019 | K192149 | MIS Dental Implant System | DZE | Substantially Equivalent | Dentsply Sirona, Inc. | accessdata.fda.gov |
| January 28, 2019 | K182228 | MIS LOCKiT Abutments System, OT-Equators and Ball Attachments | NHA | Substantially Equivalent | Mis Implants Technologies , Ltd. | accessdata.fda.gov |
| June 22, 2018 | K180282 | MIS Internal Hex Dental Implant System | DZE | Substantially Equivalent | Mis Implants Technologies , Ltd. | accessdata.fda.gov |
| March 16, 2018 | K173326 | MIS CONNECT Conical Connection Abutment | NHA | Substantially Equivalent | Mis Implants Technologies , Ltd. | accessdata.fda.gov |
| December 28, 2017 | K172505 | MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments | DZE | Substantially Equivalent | Mis Implants Technologies , Ltd. | accessdata.fda.gov |
| May 26, 2017 | K163349 | MIS V3 Conical Connection Dental Implant System | DZE | Substantially Equivalent | Mis Implants Technologies , Ltd. | accessdata.fda.gov |
| August 8, 2012 | K112162 | CONICAL CONNECTION IMPLANTS | DZE | Substantially Equivalent | Mis Implants Technologies , Ltd. | accessdata.fda.gov |
| September 15, 2011 | K103089 | SEVEN IMPLANTS; BIOCOM IMPLANTS; LANCE IMPLANTS | DZE | Substantially Equivalent | Mis - Implant Technologies , Ltd. | accessdata.fda.gov |
| January 25, 2008 | K073461 | ORTHO ANCHOR SCREWS | OAT | Substantially Equivalent | Mis Implants Technologies , Ltd. | accessdata.fda.gov |
| September 16, 2005 | K051885 | MBCP | LYC | Substantially Equivalent | Biomatlante | accessdata.fda.gov |
| June 9, 2004 | K040807 | MIS DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Mis - Implant Technologies , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Bone Grafting Material, Synthetic
- All makers of Implant, Endosseous, Root-Form
- All makers of Attachment, Precision, All
- All makers of Dental Abutment Design Software For Dental Laboratory
- All makers of Implant, Endosseous, Orthodontic
Updated February 6, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.