Uniqa Dental Implants System
by Uniqa Dental Ltd EUDAMED510(k)
Active
510(k) K180598
Overview
The Uniqa Dental Implants System is a dental implant device designed for osseointegration in the jawbone to support prosthetic restorations. It includes bone-level implants with tapered shapes, intended for single-tooth or multi-tooth replacement in both maxilla and mandible.
This system is supplied as a sterile, single-use device and is compatible with major dental implant systems. It is regulated under FDA 510(k) clearance (K180598) and EU MDR compliance, with no third-party involvement in the submission process. Implants are available in standard sizes and require surgical placement by trained dental professionals.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK180598 | Date8 Aug 2018 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- DZE
- FDA applicant
- Uniqa Dental, Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3640
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Other devices from Uniqa Dental Ltd
Questions
What types of dental restorations can the Uniqa Dental Implants System support, and how does its tapered design benefit the procedure?
The Uniqa Dental Implants System is designed to support both single-tooth and multi-tooth prosthetic restorations in either the maxilla (upper jaw) or mandible (lower jaw). Its tapered bone-level implants are engineered to enhance primary stability during placement, promoting better osseointegration with the jawbone. The tapered shape also helps distribute forces more evenly, reducing stress on surrounding bone tissue.
Is the Uniqa Dental Implants System compatible with other dental implant systems, and how does this affect my workflow?
Yes, the Uniqa Dental Implants System is explicitly designed to be compatible with major dental implant systems, meaning it can integrate with existing protocols and infrastructure in your practice. This compatibility allows for flexibility in choosing abutments, prosthetic components, and software tools, streamlining workflow without requiring additional training or equipment beyond standard dental implant procedures.
Are the Uniqa Dental Implants sterile and single-use, and what does this mean for my practice’s infection control protocols?
The Uniqa Dental Implants System is supplied as a sterile, single-use device, which eliminates the need for sterilization between patients. This design reduces the risk of cross-contamination and simplifies infection control protocols, as each implant is intended for one surgical procedure only. This also ensures consistent performance and reliability, as there is no risk of degradation from repeated use or sterilization processes.
What sizes are available for the Uniqa Dental Implants, and how do I determine the appropriate size for a patient?
The Uniqa Dental Implants System is available in standard sizes tailored to address common anatomical variations in the maxilla and mandible. The exact sizing options are not detailed here, but the system is designed to accommodate a range of bone densities and widths. Your choice of implant size should be based on a thorough preoperative assessment, including digital imaging (e.g., CBCT scans) and consultation with the manufacturer’s sizing guidelines to ensure optimal placement and long-term stability.
How does the regulatory pathway for the Uniqa Dental Implants System affect its availability or use in my practice?
The Uniqa Dental Implants System has obtained FDA 510(k) clearance (K180598) under the Traditional review pathway, which means it has been deemed substantially equivalent to a legally marketed predicate device. This clearance allows for commercial distribution and use in the U.S. without additional restrictions beyond standard dental implant protocols. Additionally, the system complies with EU MDR requirements, ensuring its availability in markets adhering to these regulations. No third-party involvement was required in the submission process, which may indicate a streamlined approval pathway.