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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
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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 7 of 42
DeviceModel / ReferenceRegistriesClassStatus
Mis MD-MACG1
FDA UDI
Class IIUnknown
Mis C1-D11500
FDA UDI
Class IIActive
Mis CS-B5375
FDA UDI
Class IIActive
Mis MF5-16330
FDA UDI
Class IIActive
Mis OE-RCP01
FDA UDI
Class IActive
Mis MD-CPK41
FDA UDI
Class IIActive
Mis C1 C1-16420
FDA UDI
Class IIActive
Mis CK-NIZ6
FDA UDI
Class IIUnknown
Mis MH-53375
FDA UDI
Class IIActive
MIS Multi Unit CM-SA171
FDA UDI
Class IIActive
Mis MF4-20420
FDA UDI
Class IIActive
Mis MW-SP102
FDA UDI
Class IActive
Mis CK-CPK41
FDA UDI
Class IIActive
Mis 4bone 4B-X1025
FDA UDI
Class IIActive
Mis CG-GRW01
FDA UDI
Class IActive
Mis MN-CPC63
FDA UDI
Class IIActive
Mis CN-HS340
FDA UDI
Class IIActive
Mis LNXC-13500
FDA UDI
Class IIActive
Mis CM-SO171
FDA UDI
Class IIActive
Mis MK-0039
FDA UDI
Class IActive
Mis MT-TDT40
FDA UDI
Class IActive
Mis MW-CPK41
FDA UDI
Class IIActive
Mis MD-MAC10
FDA UDI
Class IIActive
Mis MW-CPK64
FDA UDI
Class IIUnknown
Mis MT-TDI28
FDA UDI
Class IActive
Mis CK-CPK63-USA
FDA UDI
Class IIUnknown
Mis MG-NBM40
FDA UDI
Class IActive
Mis MK-NPC62
FDA UDI
Class IIActive
MIS Equator EK-WOE5
FDA UDI
Class IIUnknown
Mis MT-NLR20
FDA UDI
Class IActive
Mis CS-SP102
FDA UDI
Class IActive
Mis V3-13390
FDA UDI
Class IIActive
Mis MK-WPC64
FDA UDI
Class IIActive
Mis ED-I0410
FDA UDI
Class IUnknown
Mis MM-CFI48
FDA UDI
Class IIActive
Mis C1C-16330
FDA UDI
Class IIActive
Mis V3-10330
FDA UDI
Class IIActive
Mis CS-RSM10
FDA UDI
Class IActive
Mis ED-CPK64
FDA UDI
Class IIActive
MIS Equator MK-NOE5
FDA UDI
Class IIActive
Mis IC1-00350
FDA UDI
Class IIActive
Mis MH-52330
FDA UDI
Class IIActive
Mis CS-TCI33
FDA UDI
Class IIActive
Mis MD-CPK62
FDA UDI
Class IIActive
Mis Seven MF7-13420
FDA UDI
Class IIActive
Mis M7C-06600
FDA UDI
Class IIActive
Mis MN-IB121
FDA UDI
Class IIUnknown
Mis Seven MF7-13330
FDA UDI
Class IIActive
MIS Multi Unit MA-ANH17
FDA UDI
Class IIActive
Mis MK-SIZ6
FDA UDI
Class IIUnknown

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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