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Sign in to claim this brandDENTACK IMPLANTS LTD
US
Last updated May 24, 2026
What DENTACK IMPLANTS LTD makes
Dentack Implants Ltd manufactures dental implant components, including screw-type endosteal implants designed for single-tooth or multi-unit restorations, reusable surgical tools like fluted drill bits and torque wrenches, and precision attachments for laboratory use. Their portfolio also includes abutment analogs for prosthetic planning, reusable screw analogs for dental prostheses, and surgical procedure kits for implant placement. Examples include healing caps, angled and straight abutments, custom drill bits, and multi-unit abutments for implant-supported frameworks.
The company’s devices are regulated under FDA classifications, with most falling into Class I or Class II categories, requiring 510(k) or UDI compliance. These products are listed in the FDA’s 510(k) and UDI registries. 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 Dentack Implants Ltd manufacture?
Dentack Implants Ltd specializes in dental implant components and related tools. Their portfolio includes screw-type endosteal dental implants for single-tooth or multi-unit restorations, reusable surgical instruments like fluted drill bits and torque wrenches, and precision attachments for laboratory use. They also produce abutment analogs for prosthetic planning, reusable screw analogs for dental prostheses, and surgical procedure kits for implant placement. Examples include healing caps, angled and straight abutments, custom drill bits, and multi-unit abutments.
Where is Dentack Implants Ltd based?
Dentack Implants Ltd is headquartered in the United States. The company’s location is relevant for regulatory compliance and communication regarding its devices, which are designed and manufactured under U.S. standards.
Which regulatory registries list Dentack Implants Ltd’s devices?
Dentack Implants Ltd’s devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries. These registries track devices that have undergone the required premarket notification process (510(k)) and are assigned a UDI for traceability and compliance purposes.
How are Dentack Implants Ltd’s devices classified under FDA regulations?
Dentack Implants Ltd’s devices are primarily classified as Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway, such as 510(k) clearance for Class II devices, ensuring compliance with FDA requirements.
What is the significance of the device categories listed for Dentack Implants Ltd?
The device categories reflect the functional roles of Dentack Implants Ltd’s products in dental implant procedures. For example, screw endosteal implants are the foundational components placed in the jawbone, while fluted drill bits and torque wrenches are reusable surgical tools used during implant placement. Abutment analogs and precision attachments support prosthetic planning and fitting, ensuring accurate restorations. These categories help clinicians and regulators understand the intended use and integration of each device within the broader dental implant workflow.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- pyramidion-is.com
- —
- —
- [email protected]
- Phone
- +97297660379
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 514897185
Catalogue (117)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Angled MU abutment | MU-1715 | FDA UDI | Class II | Active |
| Screw Retained Abutment | SRA-15S | FDA UDI | Class II | Active |
| Healing Cap | HC-400 | FDA UDI | Class II | Active |
| Straight Plastic Abutment | SA-500PS | FDA UDI | Class II | Active |
| Straight Abutment for EX | SA-300EX | FDA UDI | Class II | Active |
| Short Driver 1.25 | DS-125 | FDA UDI | Class I | Active |
| Implant 4.1*7 | EDI-4107 | FDA UDI | Class II | Active |
| Implant Analog | IA-375 | FDA UDI | Class I | Active |
| Insertion Tool Long 2.5 | ITL-250 | FDA UDI | Class I | Active |
| Straight MU Abutment | MU-412N | FDA UDI | Class II | Active |
| Twist Drill D=2.00mm, L=7.5mm | TSD-207 | FDA UDI | Class I | Active |
| Twist Drill D=3.65mm, L=8.5mm | TSD-368 | FDA UDI | Class I | Active |
| Insertion Tool Short 2.5 | ITS-250 | FDA UDI | Class I | Active |
| Multi Unit Abutment | MU-413 | FDA UDI | Class II | Active |
| Twist Drill D=2.80mm, L=7.5mm | TSD-287 | FDA UDI | Class I | Active |
| QUAD Dental Implants and Prostheses | K152188 | FDA 510(k) | Class II | Active |
| PYRAMIDION Dental Implants and Prostheses | K180859 | FDA 510(k) | Class II | Active |
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