Bond Bone
by MIS Implants Technologies Ltd.
510(k) K101014
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK101014 | Date21 Oct 2010 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LYC
- FDA applicant
- Mis Implants Technologies , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3930
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
BondBone is a synthetic bone grafting material classified as a Bone Grafting Material, Synthetic. It is designed to support bone regeneration and integration in dental procedures, providing a scaffold for new bone formation while maintaining structural stability during healing. The material combines calcium sulfate components to facilitate biocompatibility and resorption over time.
BondBone is supplied as a sterile, single-use product intended for dental applications. It is regulated under FDA 510K clearance (K101014) and falls under the classification of Class II medical devices (device code LYC). The material is engineered for ease of handling and application in surgical sites, with no noted MRI safety restrictions. Storage and handling follow standard aseptic protocols for bone graft substitutes.
Other devices from MIS Implants Technologies Ltd.
Questions
AI-generated answers, 20 Sep 2026
What types of dental procedures is BondBone designed to support during bone regeneration?
BondBone is specifically engineered as a synthetic bone grafting material to support bone regeneration and integration in dental procedures. Its calcium sulfate composition provides a scaffold for new bone formation while maintaining structural stability during the healing process, making it suitable for applications where bone volume augmentation or defect filling is required, such as sinus lifts, ridge preservation, or extraction socket grafts.
Is BondBone intended for reuse, or is it a single-use product? How should it be handled to maintain sterility?
BondBone is supplied as a sterile, single-use product, meaning it is designed for one-time use per patient. To maintain sterility, it must be handled using standard aseptic protocols for bone graft substitutes—such as keeping the packaging intact until immediate use, avoiding contamination, and adhering to manufacturer guidelines for unpacking and application in the surgical environment.
What storage conditions are recommended for BondBone to ensure its effectiveness and shelf life?
While the exact storage conditions aren’t detailed in the provided data, BondBone, like most sterile medical devices, should be stored in a cool, dry place away from direct sunlight and extreme temperatures. The manufacturer’s packaging likely includes specific instructions for optimal preservation, such as refrigeration or room-temperature storage, so clinicians should refer to the accompanying documentation for precise guidelines to maintain sterility and efficacy.
Does BondBone have any known restrictions regarding compatibility with imaging techniques like MRI?
The provided data does not mention any MRI safety restrictions for BondBone, meaning it is not explicitly labeled as unsafe for MRI use. However, clinicians should always verify compatibility with their specific MRI equipment and protocols, as material properties can vary by model and imaging settings. If in doubt, consult the manufacturer’s technical documentation or the device’s labeling.
How is BondBone regulated in the U.S., and what does its classification as a Class II device imply for its use?
BondBone is regulated under the FDA’s 510(k) clearance pathway (K101014) and classified as a Class II medical device under product code LYC (Bone Grafting Material, Synthetic). This classification implies that while it is considered lower risk than Class III devices, it still requires compliance with FDA regulations to ensure safety and effectiveness. The device was determined to be substantially equivalent to a predicate, meaning it follows established standards for bone graft substitutes in dental applications.