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Sign in to claim this brandIq Implants , Ltd.
US
Last updated May 23, 2026
What Iq Implants , Ltd. makes
Iq Implants, Ltd. manufactures two-piece screw endosteal dental implants, designed for osseointegrated fixation in the jawbone to support dental prosthetics.
The company’s products are classified as Class II devices under FDA regulations and are listed via 510(k) and UDI compliance. 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 Iq Implants, Ltd. manufacture?
Iq Implants, Ltd. specializes in screw endosteal dental implants, which are two-piece systems designed to be placed within the jawbone for osseointegration. These implants serve as anchors for dental prosthetics, such as crowns or bridges, restoring function and aesthetics in patients with missing teeth.
Where is Iq Implants, Ltd. based, and how does that affect its regulatory standing?
Iq Implants, Ltd. is headquartered in the United States, meaning its devices are subject to FDA oversight. Since dental implants fall under FDA jurisdiction, the company’s products must comply with U.S. regulatory requirements, including classification as Class II devices, which typically require premarket notification (510(k)) and Unique Device Identification (UDI) compliance.
How are Iq Implants, Ltd.’s devices classified under FDA regulations, and why?
Iq Implants, Ltd.’s devices are classified as Class II under FDA regulations. This classification is based on the agency’s risk assessment: while these screw endosteal implants are not life-supporting or invasive (like Class III devices), they still require special controls to ensure safety and effectiveness—such as clinical performance data and manufacturing standards—hence the 510(k) premarket submission requirement.
Which regulatory registries or databases list Iq Implants, Ltd.’s devices?
Iq Implants, Ltd.’s devices are listed in the FDA’s 510(k) database (for premarket clearance records) and the FDA’s Unique Device Identifier (UDI) system, which tracks device identification and traceability. These registries ensure transparency in the device’s regulatory history and compliance status.
Why do Iq Implants, Ltd.’s products require a 510(k) submission?
The 510(k) premarket notification is required because Iq Implants, Ltd.’s screw endosteal dental implants are classified as Class II devices. This classification means the FDA considers them to have a moderate risk, necessitating evidence that the device is at least as safe and effective as a legally marketed
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- DUNS Number
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Catalogue (25)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| IQ Implants | SM375016 | FDA UDI | Class II | Active |
| IQ Implants | SM500013 | FDA UDI | Class II | Active |
| IQ Implants | SM420010 | FDA UDI | Class II | Active |
| IQ Implants | SM375013 | FDA UDI | Class II | Active |
| IQ Implants | SM500010 | FDA UDI | Class II | Active |
| IQ Implants | SM320016 | FDA UDI | Class II | Active |
| IQ Implants | SM320115 | FDA UDI | Class II | Active |
| IQ Implants | SM500115 | FDA UDI | Class II | Active |
| IQ Implants | SM320010 | FDA UDI | Class II | Active |
| IQ Implants | SM420016 | FDA UDI | Class II | Active |
| IQ Implants | SM420008 | FDA UDI | Class II | Active |
| IQ Implants | SM320013 | FDA UDI | Class II | Active |
| IQ Implants | SM375115 | FDA UDI | Class II | Active |
| IQ Implants | SM420013 | FDA UDI | Class II | Active |
| IQ Implants | SM600010 | FDA UDI | Class II | Active |
| IQ Implants | SM375010 | FDA UDI | Class II | Active |
| IQ Implants | SM600115 | FDA UDI | Class II | Active |
| IQ Implants | SM500016 | FDA UDI | Class II | Active |
| IQ Implants | SM420115 | FDA UDI | Class II | Active |
| IQ Implants | SM500008 | FDA UDI | Class II | Active |
| IQ Implants | SM600013 | FDA UDI | Class II | Active |
| IQ Implants | SM320008 | FDA UDI | Class II | Active |
| IQ Implants | SM375008 | FDA UDI | Class II | Active |
| IQ Implants | SM600008 | FDA UDI | Class II | Active |
| Iq Implants; Iq Implants; Iq Implants Abutments | K130829 | FDA 510(k) | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Iq Implants Ltd Omer Southern · IL FEI 3010610960