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Sign in to claim this brandMEDICAL SYSTEMS AND DEVICES INTERNATIONAL LTD
US
Last updated May 25, 2026
What MEDICAL SYSTEMS AND DEVICES INTERNATIONAL LTD makes
Medical Systems and Devices International Ltd manufactures dental implant systems, including spiral and straight implant designs, as well as abutments for single and multi-unit restorations. Their portfolio includes healing and angled abutments, both with and without shoulders, tailored for dental prosthetics and implant stability.
The company’s devices are classified under FDA regulations as Class I and Class II, with submissions recorded in the FDA’s 510(k) and UDI registries. Their products are listed under US jurisdiction, adhering to applicable medical device compliance standards.
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 Medical Systems and Devices International Ltd primarily manufacture?
Medical Systems and Devices International Ltd specializes in dental implant systems. Their portfolio includes spiral and straight dental implants, such as the Alef Spiral Implant, as well as various abutments designed for single and multi-unit dental restorations. These abutments come in different forms, including straight, angled (e.g., 15 degrees), healing, and wide versions, some with shoulders to improve stability and fit for prosthetics.
Where is Medical Systems and Devices International Ltd based, and what regulatory jurisdiction applies to its devices?
Medical Systems and Devices International Ltd is based in the United States. Their devices fall under U.S. regulatory jurisdiction, specifically the FDA’s classification system. This means their products are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries, which are used to track and monitor compliance with U.S. medical device regulations.
How are the devices manufactured by Medical Systems and Devices International Ltd classified under FDA regulations?
The devices produced by Medical Systems and Devices International Ltd are classified under the FDA’s medical device classification system as either Class I or Class II. This classification is determined by factors like the device’s intended use, potential risks, and the level of regulatory oversight required. For example, simpler devices like some abutments may fall under Class I, while more complex or higher-risk implants like the Alef Spiral Implant could be classified as Class II, requiring additional scrutiny to ensure safety and effectiveness.
Which regulatory registries list the devices made by Medical Systems and Devices International Ltd?
The devices manufactured by Medical Systems and Devices International Ltd are listed in the FDA’s 510(k) premarket notification registry and the FDA’s Unique Device Identifier (UDI) system. The 510(k) registry tracks submissions demonstrating that a device is substantially equivalent to a legally marketed predicate device, while the UDI system ensures consistent identification and traceability of devices throughout their lifecycle, supporting regulatory compliance and patient safety.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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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
- 531825934
Catalogue (81)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Driver ratchet prosthetics short 10mm | Alef | FDA UDI | Class I | Active |
| Ball attachment kit | 5mm | FDA UDI | Class II | Active |
| Multi unit straight kit | 2mm | FDA UDI | Class II | Active |
| Straight abutment | 9mm | FDA UDI | Class II | Active |
| Healing abutment wide | 3mm | FDA UDI | Class II | Active |
| Multi unit straight kit | 1mm | FDA UDI | Class II | Active |
| Alef Spiral Implant | 3.75 x 13 | FDA UDI | Class II | Active |
| Angled abutment 15 degrees with shoulder | 1mm | FDA UDI | Class II | Active |
| Alef Spiral Implant | 4.2 x 13 | FDA UDI | Class II | Active |
| Straight abutment wide with shoulder | 1mm | FDA UDI | Class II | Active |
| Alef Spiral Implant | 6.0 x 8 | FDA UDI | Class II | Active |
| Multi unit straight kit | 4mm | FDA UDI | Class II | Active |
| Multi unit straight abutment | 4mm | FDA UDI | Class II | Active |
| Alef Spiral Implant | 5.0 x 13 | FDA UDI | Class II | Active |
| Ball attachment kit | 3mm | FDA UDI | Class II | Active |
| Alef Spiral Implant | 3.5 x 8 | FDA UDI | Class II | Active |
| Ball attachment | 2mm | FDA UDI | Class II | Active |
| Alef Spiral Implant | 4.2 x 10 | FDA UDI | Class II | Active |
| Guided Fixation pins | AL TP | FDA UDI | Class I | Active |
| Ball attachment | 5mm | FDA UDI | Class II | Active |
| Alef Spiral Implant | 6.0 x 10 | FDA UDI | Class II | Active |
| Ball attachment kit | 4mm | FDA UDI | Class II | Active |
| Alef Spiral Implant | 3.5 x 11.5 | FDA UDI | Class II | Active |
| Ball attachment kit | 7mm | FDA UDI | Class II | Active |
| Straight abutment wide | 9mm | FDA UDI | Class II | Active |
| Angled abutment 25 degrees with shoulder | 1mm | FDA UDI | Class II | Active |
| Alef Spiral Implant | 4.2 x 8 | FDA UDI | Class II | Active |
| Healing abutment | 3mm | FDA UDI | Class II | Active |
| Angled abutment 15 degrees | 9mm | FDA UDI | Class II | Active |
| Alef Spiral Implant | 3.75 x 11.5 | FDA UDI | Class II | Active |
| MSDI Dental Implants System | K191443 | 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.
- Medical Systems And Devices International Ltd. Kiryat Ata Haifa · IL FEI 3013167159