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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 25 of 42
DeviceModel / ReferenceRegistriesClassStatus
Mis CS-LOC02
FDA UDI
Class IIActive
Mis MN-PCT11
FDA UDI
Class IUnknown
Mis V3C-13330
FDA UDI
Class IIActive
Mis C1C-13500
FDA UDI
Class IIActive
Mis CN-HA548
FDA UDI
Class IIActive
Mis MK-WLC3
FDA UDI
Class IIActive
Mis MH-W4500
FDA UDI
Class IIActive
Mis CK-SLC1
FDA UDI
Class IIActive
Mis MM-APC49
FDA UDI
Class IUnknown
Mis CW-TC023
FDA UDI
Class IIActive
Mis CN-CPK44
FDA UDI
Class IIActive
Mis ED-A2510
FDA UDI
Class IIActive
MIS Multi Unit MA-W2500
FDA UDI
Class IIActive
Mis MD-CPK82
FDA UDI
Class IIActive
Mis ED-CPK81
FDA UDI
Class IIActive
Mis VK-CPK64
FDA UDI
Class IIActive
Mis MT-CS450
FDA UDI
Class IUnknown
Mis MN-FTB15
FDA UDI
Class IIActive
Mis CM-NO301
FDA UDI
Class IIActive
Mis MT-TD280
FDA UDI
Class IUnknown
Mis MK-SDS13
FDA UDI
Class IActive
Mis MM-TC040
FDA UDI
Class IIUnknown
Mis MM-GRE10
FDA UDI
Class IActive
Mis MK-CPK42
FDA UDI
Class IIActive
Mis CK-NLC5
FDA UDI
Class IIActive
Mis Mistral MF9-10480
FDA UDI
Class IIActive
Mis MM-LOC02
FDA UDI
Class IActive
Mis MT-HMR20
FDA UDI
Class IActive
Mis CW-HA550
FDA UDI
Class IIActive
Mis MT-TF160
FDA UDI
Class IActive
Mis MT-MUMS2
FDA UDI
Class IActive
Mis MK-CPC62
FDA UDI
Class IIActive
Mis MG-NRN01
FDA UDI
Class IActive
MIS Equator CK-WOE5
FDA UDI
Class IIActive
Mis MB-RS375
FDA UDI
Class IActive
Mis MN-MC102
FDA UDI
Class IIActive
Mis MK-WPK64
FDA UDI
Class IIActive
Mis M4 MF4-08600
FDA UDI
Class IIActive
Mis VM-NO301
FDA UDI
Class IIActive
Mis C1-D16375
FDA UDI
Class IIActive
Mis M7C-13500
FDA UDI
Class IIActive
Mis CO-S0240
FDA UDI
Class IUnknown
Mis MD-MAN10
FDA UDI
Class IActive
Mis M4 MF4-13600
FDA UDI
Class IIActive
Mis EH-53410
FDA UDI
Class IIActive
MIS Ti Base MK-TBS4
FDA UDI
Class IIActive
Mis MG-D1350
FDA UDI
Class IActive
Mis EK-CPK42
FDA UDI
Class IIUnknown
Mis C1C-16375
FDA UDI
Class IIActive
Mis MM-LEL10
FDA UDI
Class IIActive

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