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MIS 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
—
Website
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LinkedIn
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Facebook
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Email
—
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 4 of 42
DeviceModel / ReferenceRegistriesClassStatus
Mis MW-MACG1
FDA UDI
Class IIUnknown
Mis VN-IO405
FDA UDI
Class IActive
Mis MH-S0648
FDA UDI
Class IIActive
Mis MG-GRI10
FDA UDI
Class IActive
Mis CS-HA375
FDA UDI
Class IIActive
Mis M7C-11500
FDA UDI
Class IIActive
Mis MT-LBT38
FDA UDI
Class IActive
Mis OE-RCW01
FDA UDI
Class IActive
Mis VK-CPK64-USA
FDA UDI
Class IIUnknown
Mis EH-W4500
FDA UDI
Class IIActive
Mis MW-RSM80
FDA UDI
Class IActive
Mis CK-CPK41-USA
FDA UDI
Class IIActive
Mis EW-P1510
FDA UDI
Class IIUnknown
Mis MK-NPK44
FDA UDI
Class IIActive
Mis MG-N1324
FDA UDI
Class IActive
Mis MD-AN251
FDA UDI
Class IIActive
Mis Uno MO1-13300
FDA UDI
Class IIActive
Mis MB-NR015
FDA UDI
Class IIUnknown
Mis MT-TDT35
FDA UDI
Class IActive
Mis Uno MO1-16350
FDA UDI
Class IIActive
Mis Lance EF5-11375
FDA UDI
Class IIActive
Mis MG-P1024
FDA UDI
Class IActive
Mis CT-P2411
FDA UDI
Class IActive
Mis CN-TCI13
FDA UDI
Class IIActive
Mis MA-NC348
FDA UDI
Class IIActive
Mis MN-AT101
FDA UDI
Class IIActive
Mis MD-RSM48
FDA UDI
Class IActive
Mis CG-D0843
FDA UDI
Class IActive
Mis VN-IO401
FDA UDI
Class IActive
MIS Ball Attachment EW-B5550
FDA UDI
Class IIUnknown
Mis Seven MF7-08420
FDA UDI
Class IIActive
Mis ED-TCH13
FDA UDI
Class IIUnknown
Mis VS-TC023
FDA UDI
Class IIActive
Mis EK-CPK64
FDA UDI
Class IIActive
MIS Equator CS-OE337
FDA UDI
Class IIActive
Mis CG-D1633
FDA UDI
Class IActive
Mis CC1-00315
FDA UDI
Class IIActive
Mis CS-A1530
FDA UDI
Class IIActive
Mis CG-NMN10
FDA UDI
Class IActive
Mis VN-P4140
FDA UDI
Class IIActive
Mis MK-CPK84
FDA UDI
Class IIActive
Mis EK-CPK82
FDA UDI
Class IIUnknown
Mis VM-NO302
FDA UDI
Class IIActive
Mis MG-D0850
FDA UDI
Class IActive
Mis MD-RSM60
FDA UDI
Class IActive
Mis MK-WPK41
FDA UDI
Class IIActive
Mis VS-AT253
FDA UDI
Class IIActive
Mis CF5C-10500
FDA UDI
Class IIActive
MIS Equator EK-SOE2
FDA UDI
Class IIUnknown
MIS Equator CW-OE550
FDA UDI
Class IIUnknown

Related Companies

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Authorities

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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