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Sign in to claim this brandMIS Implants Technologies Ltd.
US
Last updated May 23, 2026
What MIS Implants Technologies Ltd. makes
MIS Implants Technologies Ltd. manufactures dental implant suprastructures, including both permanent and single-use temporary preformed designs. Their portfolio also includes two-piece endosteal dental implants (screw and basket types), reusable surgical procedure kits for dental/maxillofacial procedures, and reusable drill bits for dental fixtures. Additionally, they produce screwing power tool attachments and fluted surgical drill bits for dental applications.
The company’s devices are classified under FDA regulations as Class I and Class II, with products listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does MIS Implants Technologies Ltd. primarily manufacture?
MIS Implants Technologies Ltd. specializes in dental implant-related devices. Their portfolio includes dental implant suprastructures (both permanent and temporary, single-use preformed types), two-piece endosteal dental implants (screw and basket designs), reusable dental/maxillofacial surgical kits, and reusable dental drill bits. They also produce screwing power tool attachments and fluted surgical drill bits for dental applications, focusing on components used in dental restoration and implantology.
Where is MIS Implants Technologies Ltd. based, and how does that affect its regulatory standing?
MIS Implants Technologies Ltd. is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The FDA classifies their products as either Class I or Class II, depending on the risk level and intended use, and some of their devices are listed in the FDA’s Unique Device Identifier (UDI) database, which helps track and regulate medical devices in the U.S. market.
Which regulatory registries or databases list MIS Implants Technologies Ltd.’s devices?
MIS Implants Technologies Ltd.’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices authorized for sale in the United States, ensuring transparency and traceability for healthcare providers and regulators. The inclusion in this database reflects compliance with FDA requirements for device identification and reporting.
How are MIS Implants Technologies Ltd.’s devices classified under FDA regulations?
The FDA categorizes MIS Implants Technologies Ltd.’s devices into Class I or Class II based on their risk levels and intended use. Class I devices generally pose minimal risk and may be exempt from some regulatory controls, while Class II devices require stricter oversight due to moderate risk. For example, reusable surgical kits and drill bits may fall under Class II due to their procedural role in dental surgery, whereas some implant components could be classified as Class I if they present lower risk. The classification determines the regulatory pathway and requirements for authorization.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 514576057
Catalogue (2090)
Page 35 of 42| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| MIS Equator | MD-OE337 | FDA UDI | Class II | Unknown |
| Mis | MK-SPZ4 | FDA UDI | Class II | Unknown |
| Mis | MG-KT01 | FDA UDI | Class I | Active |
| Mis | VK-NPK41-USA | FDA UDI | Class II | Unknown |
| Mis | MN-AT202 | FDA UDI | Class II | Active |
| Mis | CF5-16420 | FDA UDI | Class II | Active |
| Mis | MG-D0024 | FDA UDI | Class I | Active |
| Mis | MM-IOI40 | FDA UDI | Class I | Active |
| Mis | M5C-10375 | FDA UDI | Class II | Active |
| Mis | CN-IC401 | FDA UDI | Class I | Active |
| Mis | C1C-10500 | FDA UDI | Class II | Active |
| Mis | C1-D10375 | FDA UDI | Class II | Active |
| Mis | MC3-00375 | FDA UDI | Class II | Active |
| Mis | EW-PF500 | FDA UDI | Class I | Unknown |
| Mis | MK-CDS10 | FDA UDI | Class I | Active |
| Mis | EW-AN151 | FDA UDI | Class II | Unknown |
| Mis | MT-S4011 | FDA UDI | Class I | Unknown |
| Mis | MK-T051 | FDA UDI | Class I | Active |
| Mis | CN-TC013 | FDA UDI | Class II | Active |
| Mis | V3-08500 | FDA UDI | Class II | Active |
| Mis | MK-0060 | FDA UDI | Class I | Active |
| Mis | CK-WPK61 | FDA UDI | Class II | Active |
| Mis | CN-TB002 | FDA UDI | Class II | Active |
| Mis | VK-CPK82-USA | FDA UDI | Class II | Active |
| Mis | MD-RSM40 | FDA UDI | Class I | Active |
| Mis | CA-GT010 | FDA UDI | Class II | Active |
| Mis | MT-CSR21 | FDA UDI | Class I | Active |
| Mis | VG-NMN10 | FDA UDI | Class I | Active |
| Mis | CS-AT152 | FDA UDI | Class II | Active |
| Mis | MD-I0375 | FDA UDI | Class I | Active |
| Mis | MT-TDT28 | FDA UDI | Class I | Active |
| Mis | CN-TC023 | FDA UDI | Class II | Active |
| Mis | MW-CPK61 | FDA UDI | Class II | Unknown |
| Mis | MW-CPC63 | FDA UDI | Class II | Active |
| Mis | MT-LOC11 | FDA UDI | Class I | Active |
| Mis | CS-TBF30 | FDA UDI | Class II | Active |
| Mis | EH-56410 | FDA UDI | Class II | Active |
| Mis | CF5C-16420 | FDA UDI | Class II | Active |
| Mis | LNXC-16375 | FDA UDI | Class II | Active |
| Mis | CS-TC013 | FDA UDI | Class II | Active |
| Mis | MW-GPC10 | FDA UDI | Class II | Active |
| Mis | MG-D0842 | FDA UDI | Class I | Active |
| Mis | MK-0046 | FDA UDI | Class II | Unknown |
| MIS Equator | MD-OE137 | FDA UDI | Class II | Active |
| Mis | MB-DB235 | FDA UDI | Class I | Active |
| Mis | CN-IT340 | FDA UDI | Class I | Active |
| MIS Equator | CK-NOE5 | FDA UDI | Class II | Active |
| Mis | CW-AT001 | FDA UDI | Class II | Active |
| Mis | VN-DI340 | FDA UDI | Class I | Active |
| Mis | CW-SMAC1 | FDA UDI | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- MIS Implants Technologies Ltd. BAR LEV INDUSTRIAL PARK Northern · IL FEI 3004203816