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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
—
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 8 of 42
DeviceModel / ReferenceRegistriesClassStatus
Mis M4 MF4-16375
FDA UDI
Class IIActive
Mis MT-S4508
FDA UDI
Class IActive
Mis CF5C-13420
FDA UDI
Class IIActive
Mis EK-WPK64
FDA UDI
Class IIActive
Mis MW-IC040
FDA UDI
Class IActive
Mis ED-G0250
FDA UDI
Class IIUnknown
MIS Multi Unit MA-W3500
FDA UDI
Class IIUnknown
MIS Crest Widener MK-CW28
FDA UDI
Class IIActive
Mis CS-CPK84
FDA UDI
Class IIActive
Mis Seven MF7-10500
FDA UDI
Class IIActive
Mis EW-IT300
FDA UDI
Class IUnknown
Mis MD-CPC62
FDA UDI
Class IIActive
Mis EK-WPK81
FDA UDI
Class IIUnknown
Mis VS-P6155
FDA UDI
Class IIActive
Mis MD-GPCG1
FDA UDI
Class IIUnknown
Mis CW-TC013
FDA UDI
Class IIActive
Mis CS-H0343
FDA UDI
Class IIActive
MIS Ball Attachment MW-B3500
FDA UDI
Class IIActive
Mis CN-H0633
FDA UDI
Class IIActive
Mis MA-RSM10
FDA UDI
Class IUnknown
Mis MD-RAG01
FDA UDI
Class IIUnknown
Mis MG-TP047
FDA UDI
Class IActive
Mis Lance EF5-11500
FDA UDI
Class IIActive
Mis LNXC-13375
FDA UDI
Class IIActive
Mis MT-MUR02
FDA UDI
Class IActive
Mis VK-CPK82
FDA UDI
Class IIActive
Mis MF5-13600
FDA UDI
Class IIActive
Mis MF7-D16330
FDA UDI
Class IIActive
Mis CG-GRS01
FDA UDI
Class IActive
Mis MK-SDS08
FDA UDI
Class IActive
Mis MF7-D08500
FDA UDI
Class IIActive
Mis C1 C1-10420
FDA UDI
Class IIActive
Mis CW-HS350
FDA UDI
Class IIActive
Mis CK-CPK62-USA
FDA UDI
Class IIActive
Mis VK-NPK42
FDA UDI
Class IIActive
Mis MT-TDI35
FDA UDI
Class IActive
Mis CS-C3040
FDA UDI
Class IIActive
Mis LNXC-11330
FDA UDI
Class IIActive
Mis V3C-08390
FDA UDI
Class IIActive
Mis MT-TDT30
FDA UDI
Class IActive
Mis CW-HS555
FDA UDI
Class IIActive
Mis MH-N8330
FDA UDI
Class IIActive
Mis VK-NPK64-USA
FDA UDI
Class IIUnknown
MIS Equator MK-SOE4
FDA UDI
Class IIActive
Mis VN-IC440
FDA UDI
Class IActive
Mis M4 MF4-11600
FDA UDI
Class IIActive
Mis CS-AT252
FDA UDI
Class IIActive
Mis MT-S2811
FDA UDI
Class IUnknown
Mis MT-TDT50
FDA UDI
Class IActive
Mis MT-TDT55
FDA UDI
Class IActive

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