Modification to Blue Sky Bio Dental Implant System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K060957 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 Modification to Blue Sky Bio Dental Implant System is a dental implant and abutment component designed to provide support for removable or fixed dental prostheses. It is placed by clinicians into the maxilla or mandible to restore partially or fully edentulous arches, and can be used with one‑stage or two‑stage surgical protocols.
This modification is cleared under FDA 510(k) special clearance (K060957) as a substantially equivalent device to the original Blue Sky Bio Dental Implant System. It is supplied as part of the Blue Sky Bio implant system for use in dental surgical settings and is intended for clinical use in the United States.
Frequently asked questions
What is the Modification to Blue Sky Bio Dental Implant System used for?
This modification is designed to provide support for removable or fixed dental prostheses. It is placed by clinicians into the maxilla or mandible to restore partially or fully edentulous arches, and can be used with one-stage or two-stage surgical protocols.
How is the Modification to Blue Sky Bio Dental Implant System supplied?
The modification is supplied as part of the Blue Sky Bio implant system for use in dental surgical settings. It is intended for clinical use in the United States and is cleared under FDA 510(k) special clearance as a substantially equivalent device to the original Blue Sky Bio Dental Implant System.
What is the regulatory status of this dental implant modification?
This modification is cleared under FDA 510(k) special clearance (K060957) as a substantially equivalent device to the original Blue Sky Bio Dental Implant System. It is intended for clinical use in the United States and is part of the Blue Sky Bio implant system.
Can the Modification to Blue Sky Bio Dental Implant System be used with different surgical protocols?
Yes, this modification can be used with either one-stage or two-stage surgical protocols. It is designed to provide support for removable or fixed dental prostheses when placed into the maxilla or mandible to restore partially or fully edentulous arches.
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: Modification to Blue Sky Bio Dental Implant System, Modification to Blue Sky Bio Dental Implant System, Blue Sky Bio Dental Implant Systems, BIO | Max Dental Implant System | BlueSkyBio | Blue Sky Bio, PDF K060957 - Modification to Blue Sky Bio Dental Implant System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K060957 | Class II | Active |
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Manufacturer
- Manufacturer
- Blue Sky Bio Llc
- FDA Applicant
- Blue Sky Bio, LLC
Sources (1)
- FDA 510(k) K060957 24 fields · synced Oct 1, 2026