Bonalive Granules and Bonalive Plates
by Vivoxid, Ltd. EUDAMED510(k)
Active
510(k) K070055
Overview
The Bonalive Granules and Bonalive Plates are synthetic bone grafting materials designed to promote bone regeneration and integration in dental procedures. These materials are classified as bone substitutes and are intended for use in oral and maxillofacial surgery to fill defects, augment bone volume, or support bone healing.
Supplied as either granules or plates, these devices are intended for single-use applications in sterile conditions. They are classified under Class II (Device Class) and regulated under the Medical Device Directive (MDD) and FDA 510(k) clearance (K070055). Storage and handling must comply with manufacturer guidelines to maintain sterility and efficacy, with sizes and configurations tailored for dental reconstruction and implantology.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK070055 | Date25 Jun 2007 | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- LYC
- FDA applicant
- Vivoxid , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3930
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Other devices from Vivoxid, Ltd.
Questions
What types of dental procedures are Bonalive Granules and Plates intended to support, and how do they differ in their forms?
Bonalive Granules and Plates are synthetic bone substitutes designed to promote bone regeneration and integration in oral and maxillofacial surgery. They are specifically intended for filling defects, augmenting bone volume, or supporting bone healing during procedures like dental implants or reconstructions. The granules are ideal for filling irregular gaps or cavities, while the plates provide structural support in larger defects or areas requiring stabilization, offering tailored solutions for different surgical needs.
Are Bonalive Granules and Plates meant for single-use only, and how should they be stored to maintain sterility?
Yes, Bonalive Granules and Plates are explicitly designed for single-use applications in sterile conditions. To maintain sterility and efficacy, they must be stored according to the manufacturer’s guidelines, which likely include keeping them in their original packaging, protected from moisture, and away from extreme temperatures until use. Proper storage ensures the materials remain uncontaminated and ready for surgical procedures.
What regulatory pathways have been followed for Bonalive Granules and Plates, and how does this affect their use in clinical settings?
Bonalive Granules and Plates have undergone FDA 510(k) clearance (K070055) and comply with the Medical Device Directive (MDD), confirming they meet regulatory standards for synthetic bone grafting materials. This clearance indicates they are classified as Class II devices and are intended for dental applications, ensuring they are evaluated for safety and effectiveness before clinical use. Clinicians can rely on this regulatory backing when incorporating them into procedures.
Are there different sizes or configurations available for Bonalive Granules and Plates, and how might this impact their application in dental surgery?
Yes, Bonalive Granules and Plates come in various sizes and configurations tailored for dental reconstruction and implantology. The granules are available in finer or coarser forms to adapt to different defect sizes or bone augmentation needs, while the plates offer structural options for larger defects or areas requiring stabilization. This versatility allows surgeons to select the appropriate form based on the specific anatomical requirements of the patient’s procedure.