Branemark Integration BioHelix Implants
by Branemark Integration AB 510(k)
Active
510(k) K090005
Overview
The Branemark Integration BioHelix Implants are internal-connection dental implants designed for osseointegrated fixation in the jawbone. These implants are intended for use in restorative dentistry to support dental prostheses, including crowns, bridges, or overdentures, providing a stable foundation for long-term oral rehabilitation.
These implants are supplied sterile and intended for single-use, requiring surgical placement by a trained dental professional. They are classified under FDA product code DZE (Dental Implants) and were granted Special 510(k) clearance via the Dental Advisory Committee. The BioHelix design features an internal connection system, compatible with a range of abutments and components for customised restorative solutions.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK090005 | Date19 May 2009 | 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- Withdrawn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 Branemark Integration AB
Questions
Are these dental implants designed for use in both upper and lower jaws, or are they specific to one area?
The Branemark Integration BioHelix Implants are designed for osseointegrated fixation in the jawbone, which includes both the upper (maxilla) and lower (mandible) jaws. They are intended for restorative dentistry to support dental prostheses like crowns, bridges, or overdentures, providing stability for long-term oral rehabilitation in either location.
How are the BioHelix Implants supplied, and what does single-use mean in this context?
The Branemark Integration BioHelix Implants are supplied sterile, ensuring they are ready for immediate surgical use without additional sterilization. Single-use means each implant is intended for one surgical procedure only and should not be reused after placement. This ensures patient safety and maintains the integrity of the implant system.
What makes the internal connection system of these implants unique, and how does it affect restorative options?
The BioHelix Implants feature an internal connection system, which allows for greater flexibility in attaching various abutments and restorative components. This design enables customized restorative solutions, making it easier to adapt the implant to individual patient needs for crowns, bridges, or overdentures while maintaining stability.
What should clinicians consider when storing these implants before use?
Since the BioHelix Implants are supplied sterile and intended for single-use, clinicians should store them in a clean, dry environment as per the manufacturer’s instructions to preserve sterility. Proper storage ensures the implants remain uncontaminated until use, maintaining their readiness for surgical placement.