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Sign in to claim this brandETGAR - MEDICAL INSTRUMENTS LTD
US
Last updated May 23, 2026
What ETGAR - MEDICAL INSTRUMENTS LTD makes
ETGAR Medical Instruments produces dental implants and related components, including two-piece screw endosteal implants, permanent and temporary preformed suprastructures, and single-use abutments. Their portfolio also includes reusable surgical tools like screwdrivers, torque wrenches, and depth/angle gauges, as well as single-use dental impression trays and sterilization containers.
The company’s devices are regulated under FDA classifications, with most falling into Class I and Class II categories. These products are listed in the FDA’s 510(k) and UDI registries, ensuring compliance with U.S. medical device regulations.
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 ETGAR - Medical Instruments Ltd primarily manufacture?
ETGAR - Medical Instruments Ltd specializes in dental implants and associated components. Their portfolio includes two-piece screw endosteal dental implants, permanent and temporary preformed suprastructures (like abutments), single-use dental impression trays, and reusable surgical tools such as screwdrivers, torque wrenches, and depth/angle gauges. These devices support dental procedures like implant placement and restoration.
Where is ETGAR - Medical Instruments Ltd based, and how does this affect its regulatory compliance?
ETGAR - Medical Instruments Ltd is based in the United States, which means its devices are subject to FDA regulations. Since the company’s products are listed in the FDA’s 510(k) and UDI registries, they comply with U.S. requirements for medical device authorization, ensuring traceability and post-market monitoring.
Which regulatory registries list ETGAR - Medical Instruments Ltd’s devices, and why is this important?
ETGAR’s devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries. The 510(k) process demonstrates that new devices are substantially equivalent to existing ones, while UDI registration ensures standardized identification for tracking and compliance. This helps healthcare providers and regulators verify device safety and performance.
How are ETGAR - Medical Instruments Ltd’s devices classified under FDA regulations?
ETGAR’s devices fall into Class I and Class II FDA classifications. Class I devices generally pose minimal risk (e.g., single-use dental impression trays), while Class II devices require special controls to ensure safety and effectiveness (e.g., dental implants and surgical tools). The classification determines the regulatory scrutiny and documentation required for authorization.
What distinguishes ETGAR’s reusable surgical tools from their single-use dental components?
ETGAR produces both reusable tools (like surgical screwdrivers, torque wrenches, and sterilization containers) and single-use components (such as dental impression trays and temporary abutments). Reusable tools undergo rigorous cleaning and sterilization protocols to maintain safety across multiple procedures, while single-use items are designed for one-time application to minimize infection risks and ensure consistency.
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
- 514570324
Catalogue (222)
Page 2 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Esthetic Abutment Connection Screw | EIS-6707 | FDA UDI | Class II | Active |
| Abutment | EI-7515 | FDA UDI | Class II | Active |
| Healing Cap | EI-5004 | FDA UDI | Class II | Active |
| Eci Logic | ECI-6.00-L10 | FDA UDI | Class II | Active |
| Surgical Screw Driver | ET-3051 | FDA UDI | Class I | Active |
| Hand Wrench | ET-3030 | FDA UDI | Class I | Active |
| Dalrin Burnout Plastic Abutment Non Hex | EIO-8012 | FDA UDI | Class I | Active |
| Healing Cap | EI-5205 | FDA UDI | Class II | Active |
| Eci Logic | ECI-5.00-L13 | FDA UDI | Class II | Active |
| Esi Max | ESI-4.20-L11.5 | FDA UDI | Class II | Active |
| Hand Driver for Harmony/Mono Implants | EDH-0212 | FDA UDI | Class I | Active |
| Esthetic Abutment Connection Screw | EIS-6706 | FDA UDI | Class II | Active |
| Ball Attachment | EI-5506 | FDA UDI | Class II | Active |
| Container for Kit | EK-0210 | FDA UDI | Class I | Active |
| Surgical Screw Driver For Analog | ET-3052 | FDA UDI | Class I | Active |
| Abutment | EI-7115 | FDA UDI | Class II | Active |
| Hex Driver | ET-1207 | FDA UDI | Class I | Active |
| Angulated Multi Unit Adaptor | EI-4182 | FDA UDI | Class II | Active |
| Abutment | EAI-6082 | FDA UDI | Class II | Active |
| Ball Attachment | EI-5501 | FDA UDI | Class II | Active |
| Abutment | EI-7153 | FDA UDI | Class II | Active |
| Spinning Hand Ratchet | ET-3040 | FDA UDI | Class I | Active |
| Eci Logic | ECI-3.3-L13 | FDA UDI | Class II | Active |
| Healing Cap fo Multi Unit | EI-4500 | FDA UDI | Class II | Active |
| Esi Max | ESI-3.75-L13 | FDA UDI | Class II | Active |
| Eci Logic | ECI-5.00-L8 | FDA UDI | Class II | Active |
| Burnout Plastic Angulated Anatomic Abutment | EIP-7154 | FDA UDI | Class I | Active |
| Container for Kit | EK-0610 | FDA UDI | Class I | Active |
| Container for Kit | EK-0710 | FDA UDI | Class I | Active |
| Titanium Implant Analog | EIO-8081 | FDA UDI | Class I | Active |
| Transfer Screw | EI-8620 | FDA UDI | Class I | Active |
| Eh Mono | EH-4.2-L11.5 | FDA UDI | Class II | Active |
| Temporary Esthetic Burnout Plastic Abutment | EIP-6002 | FDA UDI | Class I | Active |
| Angulated Multi Unit Adaptor | EI-4303 | FDA UDI | Class II | Active |
| Esi Max | ESI-4.20-L16 | FDA UDI | Class II | Active |
| Eci Logic | ECI-3.3-L8 | FDA UDI | Class II | Active |
| Hex Driver | ET-2415 | FDA UDI | Class I | Active |
| Thru Hex Driver | 200-300-TD2.42 | FDA UDI | Class I | Active |
| Angulated Multi Unit Adaptor | EI-4181 | FDA UDI | Class II | Active |
| Eci Logic | ECI-5.00-L10 | FDA UDI | Class II | Active |
| Titanium Sleeve for Multi-Unit | EI-4498 | FDA UDI | Class II | Active |
| Esi Max | ESI-3.75-L16 | FDA UDI | Class II | Active |
| Eh Mono | EH-4.2-L10 | FDA UDI | Class II | Active |
| Dalrin Burnout Plastic Abutment with Hex | EIH-8113 | FDA UDI | Class I | Active |
| Eci Logic | ECI-3.75-L11.5 | FDA UDI | Class II | Active |
| Esthetic Abutment Connection | EIS-6701 | FDA UDI | Class II | Active |
| Plastic for Closed Tray Transfer for Multi-Unit | EI-4765 | FDA UDI | Class I | Active |
| Eh Mono | EH-3.6-L15 | FDA UDI | Class II | Active |
| M Mount Key | ET-2422 | FDA UDI | Class I | Active |
| Esi Max | ESI-3.3-L11.5 | FDA UDI | Class II | Active |
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