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Sign in to claim this brandBHI IMPLANTS LTD
US
Last updated May 24, 2026
What BHI IMPLANTS LTD makes
BHI Implants Ltd manufactures dental implant suprastructures, including permanent preformed abutments and single-use temporary variants, as well as two-piece endosteal basket implants. Their portfolio also includes reusable surgical tools like screwdrivers and drill bits, alongside surgical procedure kits for dental implant and prosthesis procedures. Additional products include specific abutment attachments such as ball attachments and healing caps.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States, adhering to applicable U.S. regulatory requirements for medical devices.
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 BHI Implants Ltd manufacture?
BHI Implants Ltd specializes in dental implant-related devices. Their portfolio includes permanent and single-use temporary dental implant suprastructures, two-piece endosteal basket implants, reusable surgical tools like screwdrivers and drill bits, and surgical procedure kits for dental implant and prosthesis procedures. Examples include abutments like the Straight Anatomic Abutment, attachments like Ball Attachments, and healing caps, all designed for dental restoration applications.
Where is BHI Implants Ltd based, and does that affect its regulatory compliance?
BHI Implants Ltd is based in the United States. Since the company operates within the U.S., its devices must comply with U.S. regulatory requirements, including classification under FDA categories and potential listing in databases like the FDA’s Unique Device Identifier (UDI) system. The location determines the applicable regulatory framework, such as FDA oversight for medical devices.
How are BHI Implants Ltd’s devices classified under U.S. regulations?
BHI Implants Ltd’s devices are classified under the FDA’s Class I and Class II categories. Class I generally includes low-risk devices requiring general controls, while Class II involves additional performance standards or special controls due to moderate risk. The classification depends on factors like the device’s intended use, potential risks, and regulatory history, as outlined in the FDA’s device classification system.
Are BHI Implants Ltd’s devices listed in any regulatory registries?
Yes, BHI Implants Ltd’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system assigns a unique product identifier to medical devices to improve tracking, reduce medical errors, and enhance transparency in the supply chain. Listing in this registry helps ensure traceability and compliance with FDA requirements for post-market surveillance.
What distinguishes BHI Implants Ltd’s reusable surgical tools from their single-use products?
BHI Implants Ltd produces both reusable tools (e.g., surgical screwdrivers and drill bits) and single-use temporary dental implant suprastructures. Reusable tools are designed for repeated use in clinical settings with appropriate sterilization between procedures, while single-use items like temporary abutments are intended for one-time application to reduce infection risks and simplify disposal. The distinction depends on the device’s purpose, risk level, and regulatory classification.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- bh-implants.com
- —
- —
- [email protected]
- Phone
- +972046094458
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 600330916
Catalogue (764)
Page 2 of 16| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Dental Solution | 1 | FDA UDI | Class I | Active |
| Conhex | 1 | FDA UDI | Class I | Active |
| Straight Multi Unit L=3 | 1 | FDA UDI | Class II | Active |
| Conhex | 1 | FDA UDI | Class II | Active |
| Lab Analog | 1 | FDA UDI | Class I | Active |
| Rosen Screw | 1 | FDA UDI | Class II | Active |
| Conhex | 1 | FDA UDI | Class II | Active |
| Motor Mount | 1 | FDA UDI | Class I | Active |
| Rosen Implant Solutions | 1 | FDA UDI | Class I | Active |
| Rosen Implant Solutions | 1 | FDA UDI | Class I | Active |
| Conhex | 1 | FDA UDI | Class I | Active |
| Conhex | 1 | FDA UDI | Class II | Active |
| Bar Abutment for 4.5 mm | 1 | FDA UDI | Class II | Active |
| Shoulder Abutment | 1 | FDA UDI | Class II | Active |
| Conhex | 1 | FDA UDI | Class II | Active |
| Shark | 1 | FDA UDI | Class II | Active |
| Dental Solution | 1 | FDA UDI | Class II | Active |
| Twist Drill | 1 | FDA UDI | Class I | Active |
| Lab Analog | 1 | FDA UDI | Class I | Active |
| Conhex | 1 | FDA UDI | Class I | Active |
| Healing Cap | 1 | FDA UDI | Class II | Active |
| InstaRisa | 1 | FDA UDI | Class I | Unknown |
| Ball Attachment | 1 | FDA UDI | Class II | Active |
| Ratchet | 1 | FDA UDI | Class I | Active |
| Conhex | 1 | FDA UDI | Class II | Active |
| Plastic Abutment | 1 | FDA UDI | Class I | Active |
| Multi Unit Analog | 1 | FDA UDI | Class I | Active |
| Dental Solution | 1 | FDA UDI | Class II | Active |
| Dental Solution | 1 | FDA UDI | Class II | Active |
| Dental Solution | 1 | FDA UDI | Class II | Active |
| SIXt | 1 | FDA UDI | Class II | Active |
| Cyclone | 1 | FDA UDI | Class II | Active |
| Straight Multi Unit L=4 | 1 | FDA UDI | Class II | Active |
| Get Implant | 1 | FDA UDI | Class II | Active |
| Angular Abutment | 1 | FDA UDI | Class II | Active |
| Bar Abutment for 3.5 mm | 1 | FDA UDI | Class II | Active |
| Rosen Implant Solutions | 1 | FDA UDI | Class II | Active |
| Titanium Sleeve for Multi Unit | 1 | FDA UDI | Class I | Active |
| Dental Solution | 1 | FDA UDI | Class II | Active |
| Conhex | 1 | FDA UDI | Class I | Active |
| SIXt | 1 | FDA UDI | Class II | Active |
| Rosen Implant Solutions | 1 | FDA UDI | Class II | Active |
| M Implants | 1 | FDA UDI | Class II | Active |
| Dental Solution | 1 | FDA UDI | Class II | Active |
| Dental Solution | 1 | FDA UDI | Class II | Active |
| Conhex | 1 | FDA UDI | Class II | Active |
| Dental Solution | 1 | FDA UDI | Class II | Active |
| Implantight | 1 | FDA UDI | Class I | Active |
| Rosen Implant Solutions | 1 | FDA UDI | Class II | Active |
| Angular Anatomic Abutment | 1 | FDA UDI | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- BHI Implants Afula Northern · IL FEI 3010393542