Bonafix 2 Plus
by Zentek Medical, LLC 510(k)
Active
510(k) K213677
Overview
Bonafix 2 Plus is an implant, endosseous, root-form device intended for use in dental applications. It is a medical device that received FDA 510(k) clearance on December 20, 2022, and is substantially equivalent to a predicate device.
The device is manufactured by Zentek Medical, LLC, located at 200 Craig Rd., Suite 107, Manalapan, NJ 07726. It is supplied as a finished implant with product code DZE and is classified as a Class II device under regulation 872.3640.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK213677 | Date20 Dec 2022 | 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- Withdrawn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 Zentek Medical LLC
Questions
What is the Bonafix 2 Plus intended for in dental procedures, and how does it differ from its predecessor?
The Bonafix 2 Plus is an endosseous, root-form dental implant designed to be placed within the jawbone for dental restoration purposes. As a substantially equivalent device to its predecessor, it follows the same core purpose of providing a stable foundation for dental prosthetics, but may include design or material refinements to improve performance or patient outcomes. Its classification as a Class II device under FDA product code DZE confirms its role in dental implantology.
Is the Bonafix 2 Plus intended for single-use or can it be reused after sterilization?
The Bonafix 2 Plus is supplied as a finished implant for single-use only. Since it is an implantable device, reuse is not recommended or supported by the manufacturer, as it could compromise patient safety and sterility. Always follow the manufacturer’s instructions for proper handling and disposal.
What are the key details about the manufacturer and how can I verify the regulatory status of this device?
The Bonafix 2 Plus is manufactured by Zentek Medical, LLC, located at 200 Craig Rd., Suite 107, Manalapan, NJ 07726. The device received FDA 510(k) clearance (K213677) on December 20, 2022, under the Dental (DE) Advisory Committee, confirming it is classified as a Class II device (product code DZE). For verification, you may reference the FDA’s database using the K-number or contact Zentek Medical directly.
How should the Bonafix 2 Plus be stored to maintain its integrity before use?
While the provided data does not specify exact storage conditions, dental implants like the Bonafix 2 Plus should generally be stored in a clean, dry environment at room temperature, protected from moisture, contamination, and physical damage. Always refer to the manufacturer’s included instructions or packaging for precise storage guidelines to ensure sterility and functionality before implantation.