Blue Sky Bio Dental Implant System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K102034 FDA 510(k)
- FDA Product Code
- DZE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3640 FDA 510(k)
- Regulation Number
- 872.3640 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Blue Sky Bio Dental Implant System is a dental implant device designed for osseointegrated replacement of missing natural teeth. It includes components for anchoring dental prosthetics in the jawbone, featuring conical connections and bioengineered threads to enhance stability and integration with surrounding bone tissue. This system is classified under dental implant devices and is intended for use in restorative dentistry procedures.
The system is supplied as a sterile, single-use or reusable implant kit, depending on component specifications, and is approved for use in dental clinics and oral surgery settings. It is regulated under FDA 510(k) clearance (K102034) and adheres to dental implant standards for biocompatibility and mechanical performance. Components are available in standardized sizes and configurations, with surgical tools and restorative elements provided for clinical use. Storage and handling follow standard sterile protocols for implantable medical devices.
Frequently asked questions
What is the Blue Sky Bio Dental Implant System used for?
The Blue Sky Bio Dental Implant System is designed specifically for osseointegrated replacement of missing natural teeth in restorative dentistry. Its conical connections and bioengineered threads improve stability and integration with the surrounding bone tissue, ensuring a secure foundation for dental prosthetics.
How is the Blue Sky Bio Dental Implant System supplied?
The system is supplied as either a sterile, single-use or reusable implant kit, depending on the specific components included. This ensures flexibility for clinical settings, whether they require disposable implants for infection control or reusable components for cost efficiency.
Is the Blue Sky Bio Dental Implant System single-use or reusable?
The system can be supplied in both single-use and reusable configurations, depending on the individual components within the kit. Single-use components are ideal for maintaining sterile protocols, while reusable parts allow for cost-effective use in controlled clinical environments.
What sizes and configurations are available for the Blue Sky Bio Dental Implant System?
The Blue Sky Bio Dental Implant System comes in standardized sizes and configurations to accommodate various clinical needs. These include components for anchoring dental prosthetics, along with surgical tools and restorative elements, ensuring compatibility with different patient anatomies and treatment plans.
How should the Blue Sky Bio Dental Implant System be stored and handled?
Storage and handling of the Blue Sky Bio Dental Implant System follow standard sterile protocols for implantable medical devices. This includes maintaining a clean, dry environment, proper packaging integrity, and adherence to manufacturer guidelines to preserve sterility and functionality before use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Blue Sky Bio Dental Implant Systems, BIO | Max Dental Implant System | BlueSkyBio | Blue Sky Bio, BlueSkyBio | Dental Implant Innovation Company & Digital Workflow Leaders, Universal Dental Implant System | BlueSkyBio Integrated Platform
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K102034 | Class II | Active |
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Manufacturer
- Manufacturer
- Blue Sky Bio Llc
- FDA Applicant
- Blue Sky Bio, LLC
Sources (1)
- FDA 510(k) K102034 24 fields · synced Oct 1, 2026