PrimeTaper EV Dental Implant
by Dentsply Sirona, Inc. 510(k)
Active
510(k) K210610
Overview
The PrimeTaper EV Dental Implant is a tapered dental implant designed for osseointegration in the jawbone. It features a progressive thread design intended to facilitate primary stability and bone engagement during placement, supporting long-term integration and load-bearing functionality. This implant is categorized under dental implant systems and is engineered for use in restorative dentistry procedures requiring stable anchorage for crowns, bridges, or other prosthetic restorations.
The PrimeTaper EV Dental Implant is supplied as a single-use, sterile device intended for surgical placement by dental professionals. It is classified under product code DZE and has received FDA 510(k) clearance through a traditional review process, demonstrating substantial equivalence to a predicate device. The implant is available in various sizes and configurations to accommodate different clinical scenarios, with no specific MRI safety restrictions noted. Storage and handling follow standard sterile medical device protocols to ensure integrity prior to use.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK210610 | Date27 Aug 2021 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DZE
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3640
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Other devices from Dentsply Sirona Inc
Questions
What is the PrimeTaper EV Dental Implant designed for?
The PrimeTaper EV Dental Implant is specifically engineered for osseointegration in the jawbone, providing stable anchorage for restorative dentistry procedures. Its progressive thread design enhances primary stability during placement, ensuring long-term integration and load-bearing support for crowns, bridges, or other prosthetic restorations. This makes it suitable for patients requiring durable, functional dental replacements.
How is the PrimeTaper EV Dental Implant supplied and what are its sterility and reuse guidelines?
The PrimeTaper EV Dental Implant is supplied as a single-use, sterile device, ensuring patient safety and compliance with surgical protocols. Due to its sterile packaging and intended single-use nature, reuse is not recommended. This aligns with standard medical device practices to prevent contamination and maintain efficacy.
What sizes and configurations are available for the PrimeTaper EV Dental Implant?
The PrimeTaper EV Dental Implant is available in multiple sizes and configurations to address diverse clinical needs. These variations allow for tailored placement in different jawbone densities and anatomical structures, ensuring adaptability for various restorative scenarios. Exact dimensions or specific models should be referenced in the product documentation or consult the manufacturer for precise sizing options.
Are there any special storage or handling instructions for this implant?
Storage and handling of the PrimeTaper EV Dental Implant follow standard sterile medical device protocols to preserve its integrity before use. This includes maintaining the sterile packaging until implantation and adhering to manufacturer guidelines for temperature and environmental conditions. Proper storage ensures the implant remains uncontaminated and ready for surgical placement.
Does the PrimeTaper EV Dental Implant have any MRI safety restrictions?
No specific MRI safety restrictions have been noted for the PrimeTaper EV Dental Implant. However, as with all medical devices, clinicians should verify compatibility with MRI systems and protocols based on individual patient needs and facility guidelines. Always consult the latest manufacturer documentation for updates or concerns regarding MRI use.